Pevonedistat + Chemotherapy for Non-Small Cell Lung Cancer

Recruiting at 12 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well MLN4924 (pevonedistat), carboplatin, and paclitaxel work in treating patients with stage IIIB or IV non-small cell lung cancer. Pevonedistat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pevonedistat together with carboplatin and paclitaxel may work better in treating patients with non-small cell lung cancer when compared with other standard chemotherapy drugs.

Research Team

Ticiana A Leal

Principal Investigator

JHU Sidney Kimmel Comprehensive Cancer Center LAO

Eligibility Criteria

This trial is for adults with stage IIIB or IV non-small cell lung cancer (NSCLC) who have previously been treated with immunotherapy. They must have a life expectancy of at least 12 weeks, acceptable liver and kidney function, controlled CNS metastases if present, and no severe heart or lung conditions. Participants need to agree to use contraception and cannot be pregnant.

Inclusion Criteria

I can understand and am willing to sign the consent form, or I have someone who can do it for me.

I agree to use effective birth control during the study.

My liver function tests are within the required range.

Exclusion Criteria

I have a serious lung condition like COPD, lung scarring, or fibrosis.

I have severe liver problems or cirrhosis.

I will not donate sperm during the study or for 4 months after the last dose.

Treatment Details

Interventions

• Carboplatin (Alkylating Agent)
• Paclitaxel (Mitotic Inhibitor)
• Pevonedistat (Enzyme Inhibitor)

Trial Overview The study tests the effectiveness of combining MLN4924 (Pevonedistat) with Carboplatin and Paclitaxel in NSCLC patients who didn't respond well to prior treatments. It aims to see if this combination is better than standard chemotherapy by blocking enzymes that help cancer cells grow.

Participant Groups

Group I: Treatment (paclitaxel, carboplatin, pevonedistat) Experimental Treatment 3 Interventions

Patients receive paclitaxel IV over 3 hours on day 1, carboplatin IV over 30-60 minutes on day 1, and pevonedistat IV over 1 hour on days 1, 3, and 5. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+