Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)

Conditions

• Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab 200 mg — BIOLOGICAL
  Pembrolizumab 200 mg Q3W
• Pembrolizumab 400 mg — BIOLOGICAL
  Pembrolizumab 400 mg Q6W
• Pembrolizumab placebo (saline) — DRUG
  Pembrolizumab placebo (saline) Q3W
• Pembrolizumab placebo (saline) — DRUG
  Pembrolizumab placebo (saline) Q6W
• Olaparib 300 mg BID — DRUG
  Olaparib 300 mg twice daily (BID)
• Olaparib matching placebo — DRUG
  Olaparib matching placebo BID
• Etoposide 100 mg/m^2 — DRUG
  Etoposide 100 mg/m\^2 intravenous (IV) Q3W, Day 1-3
• Platinum, investigator's choice — DRUG
  Carboplatin titrated to an area under the plasma drug concentration time curve (AUC) of 5 mg/mL/min IV Q3W OR Cisplatin 75 mg/m\^2 IV Q3W on Day 1 of each cycle
• Standard Thoracic Radiotherapy — RADIATION
  Standard Thoracic Radiotherapy
• Prophylactic Cranial Irradiation (PCI) — RADIATION
  PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.

Study Details

Researchers are looking for new ways to treat Limited-Stage Small Cell Lung Cancer (LS-SCLC), a type of lung cancer that has not spread from the lung to other parts of the body. The purpose of this study is to learn if pembrolizumab and olaparib, when given with chemotherapy and radiation treatment (CRT), can be effective in treating LS-SCLC. The researchers want to know if participants who receive CRT and pembrolizumab, with or without olaparib, have a longer overall survival compared to participants who only receive CRT.

Key Dates

Start date

Dec 8, 2020

Status verified

May 2026

Primary completion

Oct 28, 2027

Completion

Oct 28, 2027

Study Design

Enrollment

672 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group A - Pembrolizumab 200 mg
  Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab 200 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab 400 mg every 6 weeks (Q6W) plus olaparib matching placebo twice daily (BID) for 12 months or until specific discontinuation criteria are met.
• Experimental: Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID
  Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab 200 mg Q3W concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab 400 mg Q6W plus olaparib 300 mg BID for 12 months or until specific discontinuation criteria are met.
• Placebo Comparator: Group C (Pembrolizumab and Olaparib Matching Placebos)
  Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab placebo (saline) Q3W concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab placebo (saline) Q6W plus olaparib matching placebo for 12 months or until specific discontinuation criteria are met.

Primary Outcome Measure

Progression-free Survival Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); the time from randomization to progression or death due to any cause, whichever occurs first [ Time Frame: Up to approximately 59 months ]

Locations (35)

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