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Alkylating Agent

Chemotherapy + Nintedanib for Lung Cancer

Phase 1

Waitlist Available

Led By Tina Cascone

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status score 0-1

All patients must have lymph node evaluation of contralateral stations 2 and/or 4 to exclude N3 disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial studies the safety and best dose of drugs to treat lung cancer before surgery.

Who is the study for?

This trial is for adults with previously untreated stage IB-IIIA non-small cell lung cancer who are fit for surgery, have good performance status (able to carry out daily activities), and no history of significant bleeding or clotting events. They must not have had prior treatments for their lung cancer, no serious infections or illnesses that could interfere with the study, and they should be willing to use contraception if applicable.Check my eligibility

What is being tested?

The trial tests how well patients respond to a combination of chemotherapy drugs Cisplatin and Docetaxel along with Nintedanib—an enzyme inhibitor—before undergoing surgery. The aim is to shrink the tumor and limit the amount of normal tissue removed during surgery.See study design

What are the potential side effects?

Possible side effects include nausea, fatigue, increased risk of infection due to low blood counts, liver function changes, bleeding or clotting issues. There may also be specific reactions related to Nintedanib such as high blood pressure and gastrointestinal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My lymph nodes in specific areas have been checked to rule out advanced cancer.

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My cancer is at a specific stage and hasn't spread to more than one lymph node near my lungs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Major pathologic response rate, defined as less than or equal to 10% viable tumor cells in the resected specimen using the methods described by Pataer

Maximum tolerated dose (MTD) of nintedanib

Secondary outcome measures

Change in tumor size (Expansion phase)

Response rate after single-agent nintedanib (Expansion phase)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (cisplatin, docetaxel, nintedanib)Experimental Treatment4 Interventions

RUN-IN PHASE: Patients receive induction therapy comprising cisplatin IV over 2 hours on day 1, docetaxel IV over 1 hour on day 1, and nintedanib PO BID from day 2 of course 1 to day 7 of course 3. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery. EXPANSION PHASE: Patients receive single-agent nintedanib PO BID on days 1-28. Patients then receive 3 courses of induction chemotherapy and undergo surgery as above. Treatment continues even if patients experience disease progression, unless treatment is judged to be not in the best interest of the patient by the treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~1940

Docetaxel

1995

Completed Phase 4

~5620