Clinical Trial of MK-7684A with chemotherapy for extensive stage small cell lung cancer (ES-SCLC)
- Conditions
- Extensive-stage small-cell lung cancerMedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-005034-42-IT
- Lead Sponsor
- MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 450
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. Is male or female, at least 18 years of age at the time of providing documented informed consent.
4. Male participants are eligible to participate if they agree to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention after the last dose of the intervention is as follows:
- Etoposide, cisplatin, or carboplatin: 95 days
- Blinded study intervention: no contraception measures
• Refrain from donating sperm
PLUS either:
• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree
to remain abstinent
OR
• Must agree to use contraception unless confirmed to be azoospermic as detailed below:
- Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant.
- Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.
5. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
• Is not a WOCBP
OR
• Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a longterm and persistent basis) during the intervention period and for at least
the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to
others or freeze/store for her own use for the purpose of reproduction during this period. The length of time required to continue contraception
for each study intervention after the last dose of the intervention is as follows:
- Etoposide, cisplatin, or carboplatin: 180 days
- Blinded study intervention: 5 months
The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study intervention.
For other inclusion criteria please refer to the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 234
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 216
1. Is considered a poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease. Examples include, but are not limited to, uncontrolled major seizure disorder, unstable spinal cord compression, or severe or life-threatening superior vena cava syndrome.
2. Has received prior treatment (systemic therapy including investigational agents, curativeintent radiotherapy, or curative-intent surgical resection) for 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. Administration of killed vaccines are
allowed.
5. 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.
6. 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 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 CNS metastases and/or carcinomatous meningitis. Participants with brain metastases may participate only if they satisfy all of the following:
• Completed treatment (eg, whole brain radiation treatment, stereotactic radiosurgery, or equivalent) at least 14 days before the first dose of study intervention
• Have no evidence of new or enlarging brain metastases confirmed by posttreatment repeat brain imaging (preferably using the same modality) performed at least 4 weeks after treatment and within the screening period, and
• Are neurologically stable without the need for steroids at least 7 days before the first dose of study intervention as per local site assessment.
For other exclusion criteria please refer to the Protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. 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 Objective: 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.<br>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.<br><br>For other Secondary objectives please refer to the Protocol;Primary end point(s): 1. Overall Survival (OS);Timepoint(s) of evaluation of this end point: 1. Up to approximately 37 months
- Secondary Outcome Measures
Name Time Method