Clinical Trial of MK-7684A with chemotherapy for extensive stage small cell lung cancer (ES-SCLC)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

1 Apr 2022 → ongoing

Decision date (initial)

2023-10-04

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2023-503517-30-00

EudraCT number

2021-005034-42

WHO UTN

U1111-1287-4436

ClinicalTrials.gov

NCT05224141

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

To compare overall survival for MK-7684A in combination with etoposide/platinum followed by MK-7684A to atezolizumab in combination with etoposide/platinum followed by atezolizumab.

Secondary objectives 5

1. To compare progression-free survival per RECIST 1.1 by blinded independent central review (BICR) for MK-7684A plus etoposide/platinum followed by MK-7684A to atezolizumab plus etoposide/platinum followed by atezolizumab.
2. To evaluate objective response rate per RECIST 1.1 by BICR for MK-7684A plus etoposide/platinum followed by MK-7684A compared to atezolizumab plus etoposide/platinum followed by atezolizumab.
3. To evaluate duration of response per RECIST 1.1 by BICR for MK-7684A plus etoposide/platinum followed by MK-7684A compared to atezolizumab plus etoposide/platinum followed by atezolizumab.
4. To evaluate safety and tolerability based on proportion of adverse events.
5. To evaluate change from baseline and time to true deterioration in global health status/quality of life, physical functioning, dyspnea, cough, chest pain for MK-7684A plus etoposide/platinum followed by MK-7684A compared to atezolizumab plus etoposide/platinum followed by atezolizumab.

Conditions and MedDRA coding

Extensive-stage small-cell lung cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Has histologically or cytologically confirmed diagnosis of ES-SCLC in need of first-line therapy
2. Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition or T3-T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.
3. Males agree to use contraception, refrain from donating sperm, and abstain from heterosexual intercourse
4. Females are not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) or is a WOCBP who uses a highly effective contraceptive method, or is abstinent from heterosexual intercourse
5. Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
6. Has a predicted life expectancy of >3 months

Exclusion criteria 18

1. Is considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease
2. Has received prior treatment for Small Cell Lung Cancer (SCLC)
3. Is expected to require any other form of antineoplastic therapy for SCLC while on study
4. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
5. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
7. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
8. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
9. Has a history of severe hypersensitivity reaction (≥Grade 3) to any study intervention and/or any of its excipients
10. Has an active autoimmune disease that has required systemic treatment in past 2 years
11. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
12. Has a known history of, or active, neurologic paraneoplastic syndrome
13. Has an active infection requiring systemic therapy
14. Has a known history of human immunodeficiency virus (HIV) infection
15. Has a known history of Hepatitis B or known active Hepatitis C virus infection
16. Has had an allogenic tissue/solid organ transplant
17. Has had major surgery within prior 3 weeks or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of study intervention
18. Has symptomatic ascites or pleural effusion

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall Survival (OS)

Secondary endpoints 15

1. Progression-Free Survival (PFS)
2. Objective Response Rate (ORR)
3. Duration of Response (DOR)
4. Percentage of Participants Who Experienced an Adverse Event (AE)
5. Percentage of Participants Who Discontinued Study Treatment Due to an AE
6. 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)
7. Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
8. Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30
9. 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)
10. Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
11. Time to True Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30
12. TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
13. TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30
14. TTD in Cough Score (Item 31) on the EORTC QLQ-LC13
15. TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 1

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Hazem El-Osta

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Hazem El-Osta

Third parties 8

Locations

14 EU/EEA countries · 48 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 104 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications