Pembrolizumab + Chemotherapy for Small Cell Lung Cancer

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing new drugs combined with existing treatments and chemotherapy to see if they can better treat patients with severe, widespread lung cancer by boosting the immune system and enhancing chemotherapy effects.

Eligibility Criteria

This trial is for adults with extensive-stage small cell lung cancer who need first-line therapy. They must not be pregnant or breastfeeding, agree to contraception, have good organ function and performance status, and no prior treatments for SCLC. Exclusions include previous immunotherapy, certain heart conditions, uncontrolled diseases, recent major surgery, active infections like HIV/Hepatitis B/C, and other factors that could affect participation.

Inclusion Criteria

I am not pregnant or breastfeeding and meet the birth control requirements.

My small cell lung cancer is at stage IV.

I have been diagnosed with extensive-stage small cell lung cancer and need first-line therapy.

I can provide a sample of my tumor that hasn't been treated with radiation.

Exclusion Criteria

I have a history of or currently have a neurological disorder related to cancer.

I have received an organ or tissue transplant from another person.

I have cancer that has spread to my brain or spinal cord.

I am currently being treated for an infection.

I have been treated with drugs targeting immune checkpoints.

I have a history of inflammatory bowel disease.

I have not had major surgery in the last 3 weeks.

I have had treatment for small cell lung cancer, including trials.

I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.

My scans show my tumor is affecting major blood vessels or has hollow areas.

I have another cancer that is getting worse or was treated in the last 3 years.

I have fluid buildup in my abdomen, chest, or around my heart.

I have a condition that affects how my body absorbs medication taken by mouth.

I have not had a live vaccine in the last 30 days.

I have a history of HIV, Hepatitis B, or active Hepatitis C.

I have a severe fistula.

I have been treated for an autoimmune disease in the last 2 years.

I have or had lung inflammation that needed steroids.

Treatment Details

The study tests new drugs (MK-4830, boserolimab/MK-5890 & lenvatinib/MK-7902) combined with pembrolizumab & chemotherapy in treating ES-SCLC. It's an exploratory trial without formal hypothesis testing to assess the safety and effectiveness of these combinations as a first treatment option.

3Treatment groups

Experimental Treatment

Group I: Pembrolizumab + MK-4830 + ChemotherapyExperimental Treatment5 Interventions

Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until disease progression (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.

Group II: Pembrolizumab + Lenvatinib + ChemotherapyExperimental Treatment5 Interventions

Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally up to Cycles 1-4 cycles and up to 20 mg QD orally for Cycles 5-31 or until PD or discontinuation; etoposide 100 mg/m\^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.

Group III: Pembrolizumab + Boserolimab + ChemotherapyExperimental Treatment5 Interventions

Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.

Boserolimab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as KEYTRUDA for: