Trial Outcomes & Findings for Testing Crizotinib as a Potential Targeted Treatment in Cancers With ROS1 Genetic Changes (MATCH-Subprotocol G) (NCT NCT04439253)

Last Updated: 2026-04-29

Results Overview

Overall response rate was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) among all eligible and treated patients. Best overall response was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for the detailed definitions of response criteria. The 90% two-sided binomial exact confidence interval was calculated for ORR.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Results posted on

2026-04-29

Participant Flow

Subprotocol G was activated on August 12, 2015. A total of 5 patients were assigned to this arm after screening, 2 from screening cohort and 3 from outside assay. Of the 5 patients, 4 patients were enrolled to arm G between August 2015, and September 2018.

To be assigned to a specific MATCH subprotocol, patients needed to submit a tumor biopsy for molecular characterization and those with molecular variants addressed by treatments included in the trial entered corresponding MATCH subprotocol. For the subprotocol G, patients had to have an ROS1 translocations (other than patients with non-small cell lung cancer).

Participant milestones

Participant milestones
Measure	Treatment (Crizotinib) Patients receive crizotinib 250 mg PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Crizotinib: Given PO
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Crizotinib) Patients receive crizotinib 250 mg PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Crizotinib: Given PO
Overall Study Adverse Event	1
Overall Study Disease progression	2
Overall Study Complicating disease	1

Baseline Characteristics

Testing Crizotinib as a Potential Targeted Treatment in Cancers With ROS1 Genetic Changes (MATCH-Subprotocol G)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Crizotinib) n=4 Participants Patients receive crizotinib 250 mg PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Crizotinib: Given PO
Age, Continuous	54 years n=9 Participants
Sex: Female, Male Female	2 Participants n=9 Participants
Sex: Female, Male Male	2 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants
Race (NIH/OMB) White	4 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants

PRIMARY outcome

Timeframe: Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Population: Patients who were eligible and received protocol treatment

Outcome measures

Outcome measures
Measure	Treatment (Crizotinib) n=4 Participants Patients receive crizotinib 250 mg PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Crizotinib: Given PO
Objective Response Rate (ORR)	25 percentage of participants Interval 1.3 to 75.1

SECONDARY outcome

Timeframe: Assessed at baseline, then every 2 cycles for the first 26 cycles, and every 3 cycles thereafter until disease progression, up to 3 years post registration, from which 6-month PFS rate is determined

Population: Patients who were eligible and received protocol treatment

Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in NeuroOncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression. 6 month PFS rate was estimated using the Kaplan-Meier method, which can provide a point estimate for any specific time point.

Outcome measures

Outcome measures
Measure	Treatment (Crizotinib) n=4 Participants Patients receive crizotinib 250 mg PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Crizotinib: Given PO
6-month Progression-free Survival (PFS) Rate	50 percentage of participants Interval 22.0 to 100.0

SECONDARY outcome

Timeframe: Assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Population: Patients who were eligible and received protocol treatment

PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression.

Outcome measures

Outcome measures
Measure	Treatment (Crizotinib) n=4 Participants Patients receive crizotinib 250 mg PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Crizotinib: Given PO
Progression Free Survival (PFS)	4.3 months Interval 0.53 to Median PFS 90% CI upper bound could not be determined due to insufficient number of participants with events

Adverse Events

Treatment (Crizotinib)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Crizotinib) n=4 participants at risk Patients receive crizotinib 250 mg PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Crizotinib: Given PO
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Investigations Lymphocyte count decreased	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Renal and urinary disorders Acute kidney injury	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.

Other adverse events

Other adverse events
Measure	Treatment (Crizotinib) n=4 participants at risk Patients receive crizotinib 250 mg PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Crizotinib: Given PO
Gastrointestinal disorders Diarrhea	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Dyspepsia	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Blood and lymphatic system disorders Anemia	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
General disorders Edema limbs	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
General disorders Fatigue	50.0% 2/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
General disorders Fever	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Skin and subcutaneous tissue disorders Rash maculo-papular	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Bloating	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Constipation	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Hemorrhoids	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Nausea	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Gastrointestinal disorders Vomiting	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Investigations Alanine aminotransferase increased	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Investigations Alkaline phosphatase increased	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Investigations Aspartate aminotransferase increased	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Investigations Creatinine increased	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Investigations Lymphocyte count decreased	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Investigations Platelet count decreased	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Investigations Weight gain	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Investigations Weight loss	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Investigations White blood cell decreased	50.0% 2/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Metabolism and nutrition disorders Anorexia	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Metabolism and nutrition disorders Hyperkalemia	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Metabolism and nutrition disorders Hypoalbuminemia	50.0% 2/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Metabolism and nutrition disorders Hypocalcemia	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Metabolism and nutrition disorders Hypokalemia	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Metabolism and nutrition disorders Hypomagnesemia	50.0% 2/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Metabolism and nutrition disorders Hyponatremia	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Nervous system disorders Headache	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Eye disorders Dry eye	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.
Vascular disorders Hypertension	25.0% 1/4 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All 4 cases that received protocol treatment were monitored for adverse events.

Additional Information

Study Statistician

ECOG-ACRIN Statistical Office

Phone: 617-632-3012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60