NCT01639508

A Phase II Study of Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL Activity

Recruiting now Phase 2 Last updated 12 December 2025

What this trial tests

Phase 2 trial testing Cabozantinib in Non-Small Cell Lung Cancer in 86 participants. Currently enrolling.

Timeline

1 July 2012

Primary endpoint
1 July 2026

1 July 2026

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	86
Start date	1 July 2012
Primary completion	1 July 2026
Estimated completion	1 July 2026
Sites	7 locations across United States

Drugs / interventions tested

• Cabozantinib (CABOZANTINIB) — full drug profile →

Conditions studied

• Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• objective response rate (ORR) (Group A)
  Time frame: 12 weeks
  by RECIST v1.1 criteria to cabozantinib in patients with advanced NSCLC who have tested positive for RET Fusion
• objective response rate (ORR) (Group B)
  Time frame: 12 weeks
  by RECIST v1.1 criteria to cabozantinib in patients with advanced NSCLC whose tumors test positive for a ROS1 or NTRK fusion or MET or AXL overexpression, amplification, or mutation.

Sponsor's own description

The purpose of this phase II study is to find out what effects cabozantinib (XL184) has, good and/or bad, in patients whose tumors one of the following gene changes RET, ROS1, or NTRK fusion, or increased MET or AXL activity.

A phase II study looks at how effective a medication is at treating a specific type of cancer and collects information on the side effects of the study treatment.

RET, ROS1, or NTRK fusion or increased MET or AXL activity gene leads to lung cancer cell growth. Cabozantinib is an oral medicine that inhibits of RET, ROS1, NTRK, MET, and AXL. In addition, this drug interferes with other cell pathways that also cause cancer cells to grow, form new blood vessels, and spread to other organs of the body. The goal of using cabozantinib is to shrink the cancer and to prevent it from growing

Cabozantinib has been studied and shown to cause cancer shrinkage in other cancers such as medullary thyroid cancer and prostate cancer. We thus have a good idea of what side-effects it causes and can anticipate them.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeted therapy for non-small cell lung cancer: current standards and the promise of the future.
   Chan BA, Hughes BG. · · 2015 · cited 538× · PMID 25806345 · DOI 10.3978/j.issn.2218-6751.2014.05.01
2. TRKing down an old oncogene in a new era of targeted therapy.
   Vaishnavi A, Le AT, Doebele RC. · · 2015 · cited 483× · PMID 25527197 · DOI 10.1158/2159-8290.cd-14-0765
3. Response to MET inhibitors in patients with stage IV lung adenocarcinomas harboring MET mutations causing exon 14 skipping.
   Paik PK, Drilon A, Fan PD, Yu H, et al · · 2015 · cited 452× · PMID 25971939 · DOI 10.1158/2159-8290.cd-14-1467
4. <i>NTRK</i> gene fusions as novel targets of cancer therapy across multiple tumour types.
   Amatu A, Sartore-Bianchi A, Siena S. · · 2016 · cited 423× · PMID 27843590 · DOI 10.1136/esmoopen-2015-000023
5. Response to Cabozantinib in patients with RET fusion-positive lung adenocarcinomas.
   Drilon A, Wang L, Hasanovic A, Suehara Y, et al · · 2013 · cited 362× · PMID 23533264 · DOI 10.1158/2159-8290.cd-13-0035
6. Cabozantinib in patients with advanced RET-rearranged non-small-cell lung cancer: an open-label, single-centre, phase 2, single-arm trial.
   Drilon A, Rekhtman N, Arcila M, Wang L, et al · · 2016 · cited 357× · PMID 27825636 · DOI 10.1016/s1470-2045(16)30562-9
7. Drugging the efferocytosis process: concepts and opportunities.
   Mehrotra P, Ravichandran KS. · · 2022 · cited 319× · PMID 35650427 · DOI 10.1038/s41573-022-00470-y
8. MET-dependent solid tumours - molecular diagnosis and targeted therapy.
   Guo R, Luo J, Chang J, Rekhtman N, et al · · 2020 · cited 262× · PMID 32514147 · DOI 10.1038/s41571-020-0377-z