Cabozantinib S-malate for Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Advocate Illinois Masonic Medical Center, Chicago, IL
Lung Cancer+10 More
Cabozantinib S-malate - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing cabozantinib with or without nivolumab versus standard chemotherapy in patients with non-squamous non-small cell lung cancer. The FDA has approved the use of Arm B (cabozantinib S-malate, nivolumab) to treat patients with Lung Cancer. This is the first time that this combination of drugs has been approved to treat this particular condition. Patients in this trial will not receive a placebo.

Eligible Conditions

  • Lung Cancer
  • Recurrent Non-Squamous Non-Small Cell Lung Carcinoma
  • Stage IIIC Lung Cancer AJCC v8
  • Lung
  • Stage IVA Lung Cancer AJCC v8
  • Metastatic Non-Squamous Non-Small Cell Lung Carcinoma
  • Malignant Neoplasms
  • Stage IIIB Lung Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Every 6 weeks for the first year on study, and then every 12 weeks after year one

After 58 events (From time of randomization to documented disease progression [site review of imaging] or death from any cause, whichever occurs first)
Progression-free survival (PFS) for patient population with non-squamous no-small cell lung cancer (NSCLC)
After the completion of study treatment
Agreement between central view and site review in terms of progression-free survival
Correlative biomarker research
Week 12
Best objective response for each arm
The RECIST1.1 response at each time point
Year 3
Overall survival (OS) for each arm
Year 3
Toxicity profile of monotherapy with cabozantinib, and the combination of nivolumab and cabozantinib

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

Arm C (standard chemotherapy,cabozantinib S-malate, nivolumab)
1 of 3
Arm B (cabozantinib S-malate, nivolumab)
1 of 3
Arm A (cabozantinib S-malate)
1 of 3
Active Control
Experimental Treatment

142 Total Participants · 3 Treatment Groups

Primary Treatment: Cabozantinib S-malate · No Placebo Group · Phase 2

Arm B (cabozantinib S-malate, nivolumab)Experimental Group · 2 Interventions: Cabozantinib S-malate, Nivolumab · Intervention Types: Drug, Biological
Arm A (cabozantinib S-malate)
Drug
Experimental Group · 1 Intervention: Cabozantinib S-malate · Intervention Types: Drug
Arm C (standard chemotherapy,cabozantinib S-malate, nivolumab)ActiveComparator Group · 7 Interventions: Cabozantinib S-malate, Nab-paclitaxel, Paclitaxel, Ramucirumab, Docetaxel, Gemcitabine Hydrochloride, Nivolumab · Intervention Types: Drug, Drug, Drug, Biological, Drug, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: every 6 weeks for the first year on study, and then every 12 weeks after year one
Closest Location: Advocate Illinois Masonic Medical Center · Chicago, IL
Photo of Chicago 1Photo of Chicago 2Photo of Chicago 3
2009First Recorded Clinical Trial
0 TrialsResearching Lung Cancer
10 CompletedClinical Trials

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,930 Previous Clinical Trials
41,293,645 Total Patients Enrolled
Joel W NealPrincipal InvestigatorECOG-ACRIN Cancer Research Group
2 Previous Clinical Trials
128 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have MET exon 14 splice mutations on DNA analysis.
You are eligible for this study if you have tumors with known molecular alterations in ROS1, MET, RET, or must have progressed radiographically (per local investigator assessment) following one, but only one, line of platinum-based chemotherapy AND one, but only one, line of prior immunotherapy
Patient must have stage IV disease (includes M1a, M1b, or recurrent earlier stage disease), according to the 8th edition of the lung cancer Tumor Node Metastasis (TNM) classification system.
Patient must have predominant non-squamous histology (patients with NSCLC no otherwise specified [NOS] are eligible)
You have a mutation in MET and you are eligible for this trial.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.