Niraparib + Temozolomide for Small Cell Lung Cancer

(Relapsed SCLC Trial)

Recruiting at 10 trial locations

Overseen By Shadia Jalal, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Randomized phase 2, multicenter, biomarker directed clinical trial to assess the efficacy of PARP inhibitor plus Temozolomide (TMZ) in relapsed Small Cell Lung Cancer patients. This study will explore if the biomarkers the investigators test predict sensitivity to the combination of PARP inhibitor plus TMZ and therefore leads to a better treatment response. There are two potential tests of biomarkers that can predict who would benefit from the oral combination of PARP inhibitor with Temozolomide (TMZ), but they have not been evaluated. This study will test for this sensitivity using a biomarker (found in the blood that may be related to how a person reacts to a drug). Participants will be assigned to one of the two groups. Group 1 will be patients that test negative for the biomarker and will receive treatment with Lurbinectedin as per standard of care guidelines. Group 2 will be patients that test positive for the biomarker that will be randomly assigned to either the combination of Niraparib plus Temozolomide (TMZ) or Lurbinectedin.

Research Team

Shadia Jalal, MD

Principal Investigator

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Eligibility Criteria

This trial is for patients with relapsed Small Cell Lung Cancer. Participants must have specific biomarkers that could predict a better response to the treatment combination of Niraparib and Temozolomide (TMZ). Those without the biomarker will receive Lurbinectedin, a standard care treatment.

Inclusion Criteria

I have received immunotherapy alongside chemotherapy.

I have received Tarlatamab as my second line of treatment.

I will use two forms of birth control from screening until 6 months after the last drug dose.

Exclusion Criteria

I am currently on treatment for a serious infection.

I have previously been treated with lurbinectedin, TMZ, or niraparib.

My blood pressure is high and not well-controlled.

Treatment Details

Interventions

• Niraparib (PARP Inhibitor)
• Temozolomide (Alkylating agents)

Trial Overview The study is testing if certain blood biomarkers can indicate which patients will benefit from taking Niraparib with TMZ versus those who should receive Lurbinectedin. It's a randomized phase 2 trial where participants are divided into two groups based on their biomarker status.

Participant Groups

Group I: Study Drug Combination Experimental Treatment 1 Intervention

Biomarker positive patients will be randomized 2:1 to study drug (PARP inhibitor 200mg/day +TMZ 40mg/day daily) or (Standard of Care) Lurbinectedin 3.2mg/m2 one-hour intravenous (IV) infusion each cycle x21 days until disease progression or intolerable toxicity

Group II: Standard of Care Active Control 1 Intervention

Lurbinectedin 3.2mg/m2 one-hour intravenous (IV) infusion each cycle x21 days until disease progression or intolerable toxicity

Group III: Biomarker Negative Standard of Care Active Control 1 Intervention

Lurbinectedin 3.2mg/m2 one-hour intravenous (IV) infusion each cycle x21 days until disease progression or intolerable toxicity

Niraparib is already approved in Canada for the following indications:

Approved in Canada as Zejula for:

• Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+