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JOURNAL ONKOLOGIE – STUDIE

Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006/KEYVIBE-006)

Rekrutierend

NCT-Nummer:
NCT05298423

Studienbeginn:
Mai 2022

Letztes Update:
08.08.2024

Wirkstoff:
Pembrolizumab/Vibostolimab, Durvalumab, Cisplatin, Pemetrexed, Etoposide, Carboplatin, Paclitaxel

Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Merck Sharp & Dohme LLC

Collaborator:
-

Studienleiter

Medical Director
Study Director
Merck Sharp & Dohme LLC

Kontakt

Studienlocations
(3 von 150)

Universitaetsklinikum Schleswig-Holstein Campus Kiel-Medizinische Klinik II, Hämatologie und Onkolo
24105 Kiel
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +4943150022563» Ansprechpartner anzeigen
Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0603
13353 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +4930450665005» Ansprechpartner anzeigen
Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 2837)
65807 Springfield
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 417-269-6115» Ansprechpartner anzeigen
Central Texas Veterans health care-Oncology & Hematology ( Site 2819)
76504 Temple
United StatesAbgeschlossen» Google-Maps
Hangzhou Cancer Hospital-Medical Oncology ( Site 0302)
310002 Hangzhou
ChinaAbgeschlossen» Google-Maps
The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0301)
310009 Hangzhou
ChinaAbgeschlossen» Google-Maps
Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 0703)
115 26 Athens
GreeceRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 00302106972246» Ansprechpartner anzeigen
General Oncology Hospital of Kifissia "Agioi Anargiroi"-2nd Department of Medical Oncology ( Site 07
136 77 Nea Kifissia
GreeceRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 00302103501711» Ansprechpartner anzeigen
Istituto Nazionale Tumori IRCCS Fondazione Pascale-Oncologia medica Toraco-Polmonare ( Site 1107)
80131 Napoli
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 390817770291» Ansprechpartner anzeigen
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2401)
16247 Suwon-si
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 82312498485» Ansprechpartner anzeigen
Severance Hospital, Yonsei University Health System-Lung Cancer Center ( Site 2403)
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 820222280880» Ansprechpartner anzeigen
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit
08036 Barcelona
SpainRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +34932275402» Ansprechpartner anzeigen
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2610)
34722 Istanbul
TurkeyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 00902162803333» Ansprechpartner anzeigen
Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 2905)
25011 Kropyvnytskyi
UkraineRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +380979428527» Ansprechpartner anzeigen
Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital
79000 Lviv
UkraineRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +380677724757» Ansprechpartner anzeigen
Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council"
21029 Vinnytsia
UkraineRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 067 455 2460» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief Summary:

Researchers are looking for new ways to treat people with locally advanced non-small cell

lung cancer (NSCLC). The goal of this study is to learn if people who receive the

combination of vibostolimab and pembrolizumab (MK-7684A) live longer without the cancer

getting worse and live longer overall than people who receive durvalumab.

Ein-/Ausschlusskriterien

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria

- Has pathologically (histologically or cytologically) confirmed diagnosis of NSCLC.

- Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8

- Is determined to have unresectable, Stage III NSCLC as documented by a

multidisciplinary tumor board or by the treating physician in consultation with a

thoracic surgeon

- Has no evidence of metastatic disease, indicating Stage IV NSCLC, in whole-body

fluorodeoxyglucose (FDG)-positron emission tomography (PET) or FDG-PET/ computed

tomography (CT) and CT or magnetic resonance imaging (MRI) scans of diagnostic

quality of chest, abdomen, pelvis and brain

- Has measurable disease as defined by RECIST 1.1, with at least 1 lesion being

appropriate for selection as a target lesion, as determined by local site

investigator/radiology review

- Has not received prior treatment (chemotherapy, targeted therapy, or radiotherapy)

for their Stage III NSCLC

- Has provided tumor tissue sample (tissue biopsy [core, incisional, or excisional])

- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

assessed within 7 days prior to the first administration of study intervention

- Has a life expectancy of at least 6 months

Exclusion Criteria

- Has small cell lung cancer (SCLC) or tumors with the presence of small cell

elements. Mixed squamous/nonsquamous tumors are eligible

- Has received prior radiotherapy to the thorax, including radiotherapy to the

esophagus, mediastinum, or for breast cancer

- Has received major surgery (with the exception of replacement of vascular access)

within 4 weeks before randomization. If the participant had a major operation, the

participant must have recovered adequately from the procedure and/or any

complications from the operation before starting study intervention

- Is expected to require any other form of antineoplastic therapy, while on study

- Has received colony-stimulating factors (e.g., Granulocyte Colony-Stimulating Factor

[G-CSF], Granulocyte Macrophage Colony-Stimulating Factor [GM-CSF], or recombinant

erythropoietin) within 28 days prior to the first dose of study intervention

- Has received a live or live-attenuated vaccine within 30 days before the first dose

of study intervention

- Is currently participating in or has participated in a study of an investigational

agent or has used an investigational device within 4 weeks before the first dose of

study intervention

- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy

(in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of

immunosuppressive therapy within 7 days prior to the first dose of study medication

- Has a known additional malignancy that is progressing or has required active

treatment within the past 5 years

- Has an active autoimmune disease that has required systemic treatment in past 2

years

- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required

steroids or has current pneumonitis/interstitial lung disease

- Has an active infection requiring systemic therapy

- Has a known history of human immunodeficiency virus (HIV) infection

- Has a known history of Hepatitis B (defined as hepatitis B surface antigen [HBsAg]

reactive) or known active Hepatitis C virus (defined as HCV ribonucleic acid [RNA]

qualitative is detected) infection

- Has had an allogenic tissue/solid organ transplant

Pemetrexed-specific Criteria:

- Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs

(NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days

for long-acting agents [for example, piroxicam]) before, during, and for at least 2

days after administration of pemetrexed

- Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone

Studien-Rationale

Primary outcome:

1. Progression-Free Survival (PFS) For All Participants (Time Frame - Up to approximately 55 months):
PFS is defined as the time from randomization to the first documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. PFS per RECIST 1.1 will be assessed by blinded independent central review (BICR).

2. Progression-Free Survival (PFS) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% (Time Frame - Up to approximately 55 months):
PFS is defined as the time from randomization to the first documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. PFS per RECIST 1.1 will be assessed by blinded independent central review (BICR).

3. Overall Survival (OS) For All Participants (Time Frame - Up to approximately 75 months):
OS is defined as the time from randomization to death due to any cause.

4. Overall Survival (OS) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% (Time Frame - Up to approximately 75 months):
OS is defined as the time from randomization to death due to any cause.

Secondary outcome:

1. Objective Response Rate (ORR) For All Participants (Time Frame - Up to approximately 75 months):
ORR is defined as the percentage of participants who have a best response of confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). CR or PR by RECIST 1.1 will be assessed by blinded independent central review (BICR).

2. Objective Response Rate (ORR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% (Time Frame - Up to approximately 75 months):
ORR is defined as the percentage of participants who have a best response of confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). CR or PR by RECIST 1.1 will be assessed by blinded independent central review (BICR).

3. Number of Participants Who Experience at Least One Adverse Event (AE) (Time Frame - Up to approximately 75 months):
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

4. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) (Time Frame - Up to approximately 75 months):
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

5. Duration of Response (DOR) For All Participants (Time Frame - Up to approximately 75 months):
Duration of Response (DOR) is the time from first documented evidence of Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) until progressive disease (PD) or death. DOR per RECIST 1.1 will be assessed by blinded independent central review (BICR).

6. Duration of Response (DOR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% (Time Frame - Up to approximately 75 months):
Duration of Response (DOR) is the time from first documented evidence of Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) until progressive disease (PD) or death. DOR per RECIST 1.1 will be assessed by blinded independent central review (BICR).

7. Change from Baseline in the Global Health Status /Quality of Life Items 29 and 30 Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) For All Participants (Time Frame - Baseline (at randomization) and at the end of study (approximately 75 months post randomization)):
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.

8. Change from Baseline in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1% (Time Frame - Baseline (at randomization) and at the end of study (approximately 75 months post randomization)):
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.

9. Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants (Time Frame - Baseline (at randomization) and at the end of study (approximately 75 months post randomization)):
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a higher score indicating a better quality of life.

10. Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1% (Time Frame - Baseline (at randomization) and at the end of study (approximately 75 months post randomization)):
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a higher score indicating a better quality of life.

11. Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) For All Participants (Time Frame - Baseline (at randomization) and at the end of study (approximately 75 months post randomization)):
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing.

12. Change from Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1% (Time Frame - Baseline (at randomization) and at the end of study (approximately 75 months post randomization)):
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing.

13. Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants (Time Frame - Baseline (at randomization) and at the end of study (approximately 75 months post randomization)):
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain.

14. Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1% (Time Frame - Baseline (at randomization) and at the end of study (approximately 75 months post randomization)):
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain.

15. Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants (Time Frame - Baseline (at randomization) and at the end of study (approximately 75 months post randomization)):
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea.

16. Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1% (Time Frame - Baseline (at randomization) and at the end of study (approximately 75 months post randomization)):
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea.

17. Time to True Deterioration (TTD) in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For All Participants (Time Frame - Up to approximately 75 months post randomization):
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.

18. Time to True Deterioration (TTD) in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1% (Time Frame - Up to approximately 75 months post randomization):
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.

19. Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants (Time Frame - Up to approximately 75 months post randomization):
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of function. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.

20. Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1% (Time Frame - Up to approximately 75 months post randomization):
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of function. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.

21. Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For All Participants (Time Frame - Up to approximately 75 months post randomization):
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.

22. Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1% (Time Frame - Up to approximately 75 months post randomization):
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.

23. Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants (Time Frame - Up to approximately 75 months post randomization):
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.

24. Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1% (Time Frame - Up to approximately 75 months post randomization):
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.

25. Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants (Time Frame - Up to approximately 75 months post randomization):
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.

26. Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1% (Time Frame - Up to approximately 75 months post randomization):
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.

Studien-Arme

  • Experimental: pembrolizumab/vibostolimab coformulation+chemotherapy+radiotherapy
    For the first 3 cycles, participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) intravenously (IV) on Day 1 plus 3 cycles of investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray [Gy] in 2 Gy fractions for 30 days total) during Cycles 2, 3. Participants receive pembrolizumab/vibostolimab for Cycles 4-20 or until discontinuation (up to ~14 months). Cycles 1-20 are 21-day cycles. Investigator's choice of chemotherapy: cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of Cycles 1-3 for non-squamous histology only; cisplatin 50 mg/m^2 on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3 and etoposide 50 mg/m^2 on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3 and paclitaxel 200 mg/m^2 on Day 1 of Cycle 1 and 45 mg/m^2 on Days 1, 8, 15 of Cycles 2-3.
  • Active Comparator: chemotherapy+radiotherapy+durvalumab
    For the first 3 cycles, participants will receive investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy in 2 Gy fractions for 30 days total) during Cycles 2 and 3. Following concurrent chemoradiotherapy (cCRT), participants receive durvalumab 10 mg/kg every 2 weeks for up to an additional 26 cycles or until discontinuation (up to approximately 14 months). cCRT Cycles 1-3=21-day cycles; durvalumab Cycles 1-26=14-day cycles. Investigator's choice of chemotherapy: cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of Cycles 1-3 for non-squamous histology only; cisplatin 50 mg/m^2 on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3 and etoposide 50 mg/m^2 on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3 and paclitaxel 200 mg/m^2 on Day 1 of Cycle 1 and 45 mg/m^2 on Days 1, 8, 15 of Cycles 2-3.

Geprüfte Regime

  • pembrolizumab/vibostolimab (MK-7684A):
    Administered as an intravenous (IV) infusion
  • durvalumab (IMFINZI®):
    Administered as an IV infusion
  • cisplatin (PLATINOL-AQ®):
    Administered as an IV infusion
  • pemetrexed (ALIMTA®):
    Administered as an IV infusion
  • etoposide (TOPOSAR®):
    Administered as an IV infusion
  • carboplatin (PARAPLATIN®):
    Administered as an IV infusion
  • paclitaxel (TAXOL®):
    Administered as an IV infusion
  • thoracic radiotherapy:
    Administered as an external beam radiation

Quelle: ClinicalTrials.gov


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"Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006/KEYVIBE-006)"

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