Trial Outcomes & Findings for Binimetinib and Hydroxychloroquine in Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer (NCT NCT04735068)
NCT ID: NCT04735068
Last Updated: 2025-04-01
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
16 months
Results posted on
2025-04-01
Participant Flow
Participant milestones
| Measure |
Single Arm: Hydroxychloroquine + Binimetinib
Hydroxychloroquine (HCQ) 400 mg twice daily Binimetinib - 45 mg twice daily
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Binimetinib and Hydroxychloroquine in Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Binimetinib and Hydroxychloroquine
n=9 Participants
Hydroxychloroquine (HCQ)in combination with Binimetinib (B). The starting dose for HCQ will be 400mg. Tablets of HCQ are available in 200 mg strength. HCQ will be administered in divided doses (every 12 hours) with or without food.
The starting dose of B is 45mg. B will be administered in divided doses (every 12 hours) with or without food
Binimetinib Pill: Patients will be treated with B 45 mg two times daily and HCQ 400 mg twice daily beginning on day 1. The dose of HCQ is based on an ongoing Phase 1 trial, and may be modified in a future amendment prior to the first patient enrolled. Efforts will be made to ensure dose homogeneity throughout the trial. Treatment will be administered on an outpatient basis on a 28 day cycle
Hydroxychloroquine Pill: Patients will be treated with B 45 mg two times daily and HCQ 400 mg twice daily beginning on day 1. The dose of HCQ is based on an ongoing Phase 1 trial, and may be modified in a future amendment prior to the first patient enrolled. Efforts will be made to ensure dose homogeneity throughout the trial. Treatment will be administered on an outpatient basis on a 28 day cycle
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 monthsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Single Arm: Hydroxychloroquine + Binimetinib
n=9 Participants
Hydroxychloroquine (HCQ) 400 mg twice daily Binimetinib - 45 mg twice daily
|
|---|---|
|
Objective Response Rate
|
9 Participants
|
PRIMARY outcome
Timeframe: 16 monthsas assessed by CTCAE v5.0
Outcome measures
| Measure |
Single Arm: Hydroxychloroquine + Binimetinib
n=9 Participants
Hydroxychloroquine (HCQ) 400 mg twice daily Binimetinib - 45 mg twice daily
|
|---|---|
|
Number of Patients With Adverse Events
|
9 Participants
|
SECONDARY outcome
Timeframe: 16 monthsOutcome measures
| Measure |
Single Arm: Hydroxychloroquine + Binimetinib
n=9 Participants
Hydroxychloroquine (HCQ) 400 mg twice daily Binimetinib - 45 mg twice daily
|
|---|---|
|
Progression-free Survival (PFS)
|
1 Participants
|
SECONDARY outcome
Timeframe: 16 monthsOutcome measures
| Measure |
Single Arm: Hydroxychloroquine + Binimetinib
n=9 Participants
Hydroxychloroquine (HCQ) 400 mg twice daily Binimetinib - 45 mg twice daily
|
|---|---|
|
Overall Survival (OS)
|
1 Participants
|
Adverse Events
Single Arm: Hydroxychloroquine + Binimetinib
Serious events: 4 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Single Arm: Hydroxychloroquine + Binimetinib
n=9 participants at risk
Hydroxychloroquine (HCQ) 400 mg twice daily Binimetinib - 45 mg twice daily
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
3/9 • Number of events 3 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Single Arm: Hydroxychloroquine + Binimetinib
n=9 participants at risk
Hydroxychloroquine (HCQ) 400 mg twice daily Binimetinib - 45 mg twice daily
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
6/9 • Number of events 14 • 2 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Investigations
ALT Increase
|
11.1%
1/9 • Number of events 3 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
11.1%
1/9 • Number of events 2 • 2 years
|
|
Investigations
AST Increased
|
11.1%
1/9 • Number of events 4 • 2 years
|
|
Gastrointestinal disorders
Collitis
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Dry Mouth
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry Skim
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
General disorders
Edema Face
|
22.2%
2/9 • Number of events 2 • 2 years
|
|
Cardiac disorders
Sinus Bradycardia
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Eye disorders
Subfoveal Serous Detachment
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
General disorders
Fatigue
|
33.3%
3/9 • Number of events 3 • 2 years
|
|
General disorders
Under Tongue Swelling
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9 • Number of events 4 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
3/9 • Number of events 3 • 2 years
|
|
Eye disorders
Retinal Detachment
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Vomitting
|
22.2%
2/9 • Number of events 2 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place