NCT03088930

Evaluating Crizotinib in the Neoadjuvant Setting in Patients With Non-small Cell Lung Cancer

Completed Phase 2 Results posted Last updated 11 February 2022

What this trial tests

Phase 2 trial testing Crizotinib in Lung Cancer, Nonsmall Cell in 3 participants. Completed in 13 January 2021.

Timeline

13 December 2017

Primary endpoint
13 January 2021

13 January 2021

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	13 December 2017
Primary completion	13 January 2021
Estimated completion	13 January 2021
Sites	1 location across United States

Drugs / interventions tested

• Crizotinib (crizotinib) — full drug profile →

Conditions studied

• Lung Cancer, Nonsmall Cell — all drugs for Lung Cancer, Nonsmall Cell →

Sponsor

University of Colorado, Denver

Who can join

Adults 18 to 100, any sex, with Lung Cancer, Nonsmall Cell. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Number of Participants With an Objective Tumor Response Rate Primary · 6 weeks

Participants' tumor response to treatment will be compared from initial/pretreatment scan to 6 week scan using RECIST 1.1

Group	Value	95% CI
Neoadjuvant Treatment With Crizotinib	3

The Number of Participants With Pathologic Response Rate Secondary · 37 months

Pathologic response rate is defined as \< 50% of viable tumor present histologically in the resected tumor specimen.

Group	Value	95% CI
Neoadjuvant Treatment With Crizotinib	0

Number of Participants With an Objective Response Rate Secondary · 6 weeks post treatment

Number of participants with response rate per RECIST 1.1

Group	Value	95% CI
Neoadjuvant Treatment With Crizotinib	0

The Number of Participants With Disease-free Survival (DFS) Secondary · 37 months

DFS is defined as the time from treatment to the first of either disease recurrence or death from any cause.

Group	Value	95% CI
Neoadjuvant Treatment With Crizotinib	0

Overall Survival (OS) Measured in Months Secondary · 37 months

OS is defined as the time from study enrollment to death from any cause.

Group	Value	95% CI
Neoadjuvant Treatment With Crizotinib	37	0 – 37

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Neoadjuvant Treatment With Crizotinib

Serious: 0/3 (0%)

Deaths: 1/3

Other adverse events (14 terms — click to expand)

Reaction	System	Neoadjuvant Treatment With…
Diarrhea	Gastrointestinal disorders	—
blurred vision	Eye disorders	—
Nausea	Gastrointestinal disorders	—
Insomnia	General disorders	—
Influenza	Respiratory, thoracic and mediastinal disorders	—
creatinine increased	Blood and lymphatic system disorders	—
cough	Respiratory, thoracic and mediastinal disorders	—
headache	General disorders	—
epigastric discomfort	Gastrointestinal disorders	—
bradycardia	Cardiac disorders	—
ALT increased	Blood and lymphatic system disorders	—
dysgeusia	Gastrointestinal disorders	—
dermatitis	Skin and subcutaneous tissue disorders	—
fatigue	General disorders	—

Data from ClinicalTrials.gov NCT03088930 adverse events section.

Sponsor's own description

This study will evaluate the efficacy of crizotinib as induction therapy in participants with surgically resectable ALK rearrangement, ROS1 rearrangement, or MET exon 14 mutation positive NSCLC.

Publications & conference data

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

1. Therapy-Induced Evolution of Human Lung Cancer Revealed by Single-Cell RNA Sequencing.
   Maynard A, McCoach CE, Rotow JK, Harris L, et al · · 2020 · cited 570× · PMID 32822576 · DOI 10.1016/j.cell.2020.07.017
2. Targeted Therapies in Early Stage NSCLC: Hype or Hope?
   Friedlaender A, Addeo A, Russo A, Gregorc V, et al · · 2020 · cited 75× · PMID 32878298 · DOI 10.3390/ijms21176329
3. Focus on ROS1-Positive Non-Small Cell Lung Cancer (NSCLC): Crizotinib, Resistance Mechanisms and the Newer Generation of Targeted Therapies.
   D'Angelo A, Sobhani N, Chapman R, Bagby S, et al · · 2020 · cited 66× · PMID 33172113 · DOI 10.3390/cancers12113293
4. Current and future treatment options for <i>MET</i> exon 14 skipping alterations in non-small cell lung cancer.
   Hong L, Zhang J, Heymach JV, Le X. · · 2021 · cited 50× · PMID 33643443 · DOI 10.1177/1758835921992976
5. Safety and efficacy of anaplastic lymphoma kinase tyrosine kinase inhibitors in non‑small cell lung cancer (Review).
   Wang L, Wang W. · · 2021 · cited 42× · PMID 33200229 · DOI 10.3892/or.2020.7851
6. Targeting ALK Rearrangements in NSCLC: Current State of the Art.
   Peng L, Zhu L, Sun Y, Stebbing J, et al · · 2022 · cited 39× · PMID 35463328 · DOI 10.3389/fonc.2022.863461
7. Early-stage anaplastic lymphoma kinase (<i>ALK</i>)-positive lung cancer: a narrative review.
   Chen MF, Chaft JE. · · 2023 · cited 23× · PMID 36895922 · DOI 10.21037/tlcr-22-631
8. Mechanisms of rapid cancer cell reprogramming initiated by targeted receptor tyrosine kinase inhibitors and inherent therapeutic vulnerabilities.
   Kleczko EK, Heasley LE. · · 2018 · cited 20× · PMID 29458371 · DOI 10.1186/s12943-018-0816-y