ES-SCLC small cell lung cancer
Conditions
Interventions
Intervention Group A:
- MK-7684A - 200 mg/200 mg
until discontinuation criteria
are met
- Saline placebo - at Cycle 1 (and Q3W as needed beyond Cycle 1)
as needed beyond Cycle 1
- Etoposide - 100 mg (may vary according to supplier/country)
IV
infusion
up to 4 cycles
- Cisplatin - 50 mg (may vary according to supplier/country)
up to 4 cycles
OF
- Carboplatin - 600 mg (may vary according to supplier/country)
up to 4 cycles
Intervention Group B:
- Atezolizumab - 1200 mg
until discontinuation criteria are
met
- Saline placebo - at Cycle 1 (and Q3W as needed beyond Cycle 1)
Sponsors
Merck Sharp & Dohme (MSD)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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. - A WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention. - If a urine test cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. - Additional requirements for pregnancy testing during and after study intervention are in Section 8.3.6 of the protocol. - The investigator is responsible for review of medical history, menstrual <b
Exclusion criteria
Exclusion criteria: 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. Has received an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study administration. 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. 9. Has a history of severe hypersensitivity reaction (>=Grade 3) to any study intervention and/or any of its excipients (refer to the IB and/or approved product label(s) for a list of excipients). 10. Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. 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 HIV infection. No HIV testing is required unless mandated by local health authority. 15. Has a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. 16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to partici
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Overall Survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 QLQC30 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 | — |
Countries
Netherlands
Outcome results
None listed