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Rucaparib + Nivolumab for Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By Aman Chauhan, MD
Research Sponsored by Aman Chauhan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with histologically or cytologically confirmed stage IV, extensive stage, small cell lung cancer who achieved either partial or complete remission per RECIST 1.1 post frontline chemotherapy with platinum doublet (Cisplatin or Carboplatin/etoposide).
Adequate Hepatic Function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-3 years
Awards & highlights

Study Summary

This trial will test a new combination of drugs to see if it can help people with small cell lung cancer live longer.

Who is the study for?
This trial is for adults with stage IV small cell lung cancer who've responded well to initial chemo. They must have finished their last chemo within 6 weeks, be fairly active (ECOG ≤ 2), and have good bone marrow and liver function. People can't join if they're allergic to the drugs being tested, had certain immune treatments before, suffer from autoimmune diseases or severe prior treatment side effects, are pregnant, have hepatitis B/C or HIV/AIDS, recently had a vaccine or major surgery, use strong immunosuppressants, have untreated brain metastases or another active cancer.Check my eligibility
What is being tested?
The study tests Rucaparib combined with Nivolumab as maintenance therapy in patients whose small cell lung cancer has improved after platinum-based chemotherapy. The goal is to see if this drug combo helps patients live longer and keeps their cancer from worsening.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the medications; immune-related issues affecting organs; fatigue; blood count changes; liver problems; risk of infections due to weakened immunity; potential complications for those with pre-existing heart conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My small cell lung cancer is in stage IV, and I've responded well to my first round of chemotherapy.
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My liver is functioning well.
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I finished my 4th chemotherapy cycle less than 6 weeks ago.
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My bone marrow is working well.
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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival
Secondary outcome measures
Disease Control Rate
Objective Response Rate
Overall Survival
+3 more
Other outcome measures
PD-L1 CPS
Tumor Mutation Burden

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with Stage IV SCLCExperimental Treatment1 Intervention
Patients with extensive stage (IV) SCLC (small cell lung cancer)

Find a Location

Who is running the clinical trial?

Aman ChauhanLead Sponsor
2 Previous Clinical Trials
3 Total Patients Enrolled
Zhonglin HaoLead Sponsor
3 Previous Clinical Trials
15 Total Patients Enrolled
Clovis Oncology, Inc.Industry Sponsor
63 Previous Clinical Trials
10,138 Total Patients Enrolled

Media Library

Rucaparib and Nivolumab Clinical Trial Eligibility Overview. Trial Name: NCT03958045 — Phase 2
Small Cell Lung Cancer Research Study Groups: Patients with Stage IV SCLC
Small Cell Lung Cancer Clinical Trial 2023: Rucaparib and Nivolumab Highlights & Side Effects. Trial Name: NCT03958045 — Phase 2
Rucaparib and Nivolumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT03958045 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are engaged in this research?

"Affirmative. Clinicaltrials.gov data reveals that this investigation, which was inaugurated on September 4th 2019, is actively enrolling participants. 36 volunteers are necessary between 1 trial site."

Answered by AI

What medical conditions have been treated with the combination of Rucaparib and Nivolumab?

"This combination drug is employed to treat malignant neoplasms and has been seen to be efficacious in treating conditions such as non-operable melanoma, squamous cell carcinoma, and metastasized esophageal adenocarcinomas."

Answered by AI

Have Rucaparib and Nivolumab been given the regulatory go-ahead by the FDA?

"While there is evidence to suggest a degree of safety, considering this experiment is only at Phase 2, the safety rating for Rucaparib and Nivolumab has been calculated as 2."

Answered by AI

Have there been any investigations focusing on the combination of Rucaparib and Nivolumab?

"Currently, there are 87 Phase 3 studies examining the effects of Rucaparib and Nivolumab with 743 live trials in total. Columbus, Ohio is a popular hub for this research but it can be found at over 41991 locations across the globe."

Answered by AI

Is enrollment still open for this medical research?

"Clinicaltrials.gov reports that this medical trial is still open to applicants and was initially posted on the 4th of September 2019, with its last update taking place on November 10th 2022."

Answered by AI

Is this a pioneering or groundbreaking trial?

"Since 2012, studies have been conducted to investigate the application of Rucaparib and Nivolumab. Commencing with a 659-subject trial sponsored by Ono Pharmaceutical Co. Ltd., this drug has since advanced through Phase 1 & 2 trials and is now being used in 743 live experiments across 2389 cities and 49 countries worldwide."

Answered by AI
~6 spots leftby Mar 2025