Trial Outcomes & Findings for Platinum-Based Chemotherapy Plus Ramucirumab in Patients With Advanced NSCLC Who Have Progressed on First Line Anti-PD-1 Immunotherapy (NCT NCT03904108)

Last Updated: 2022-05-26

Results Overview

Objective response (OR) is the occurrence of CR or PR as the best overall response. OR will be based on responses confirmed using the subsequent 6-weekly scan. OR is based on the 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

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

≥18 weeks, up to maximum of 12 months

Results posted on

2022-05-26

Participant Flow

Participant milestones

Participant milestones
Measure	Ramucirumab Ramucirumab 10 mg/kg IV day 1, every 3 weeks for 4 cycles Ramucirumab: platinum doublets chemotherapy plus ramucirumab, intravenously(IV)
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Platinum-Based Chemotherapy Plus Ramucirumab in Patients With Advanced NSCLC Who Have Progressed on First Line Anti-PD-1 Immunotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ramucirumab n=3 Participants Ramucirumab 10 mg/kg IV day 1, every 3 weeks for 4 cycles Ramucirumab: platinum doublets chemotherapy plus ramucirumab, intravenously(IV)
Age, Customized Age Range 58-66 years	3 participants n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Race/Ethnicity, Customized white,non-Hispanic	3 Participants n=99 Participants

PRIMARY outcome

Timeframe: ≥18 weeks, up to maximum of 12 months

Population: Data were not collected

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Through study completion, up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment

Adverse events will be recorded in relation to each cycle of treatment and graded according to CTCAE criteria. The toxicity co-primary outcome measure for the trial is defined as the occurrence of a treatment-related dose delay or treatment discontinuation due to toxicity

Outcome measures

Outcome measures
Measure	Ramucirumab n=3 Participants Ramucirumab 10 mg/kg IV day 1, every 3 weeks for 4 cycles Ramucirumab: platinum doublets chemotherapy plus ramucirumab, intravenously(IV)
Number of Participants With Treatment Related Dose Delay or Treatment Discontinuation	3 Participants

Adverse Events

Ramucirumab

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Ramucirumab n=3 participants at risk Ramucirumab 10 mg/kg IV day 1, every 3 weeks for 4 cycles Ramucirumab: platinum doublets chemotherapy plus ramucirumab, intravenously(IV)
Infections and infestations Neutropenic fever	33.3% 1/3 • Number of events 1 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Infections and infestations pneumonia	66.7% 2/3 • Number of events 3 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Respiratory, thoracic and mediastinal disorders bronchial occlusion	33.3% 1/3 • Number of events 2 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Respiratory, thoracic and mediastinal disorders respiratory failure	33.3% 1/3 • Number of events 1 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment

Other adverse events

Other adverse events
Measure	Ramucirumab n=3 participants at risk Ramucirumab 10 mg/kg IV day 1, every 3 weeks for 4 cycles Ramucirumab: platinum doublets chemotherapy plus ramucirumab, intravenously(IV)
Blood and lymphatic system disorders anemia	66.7% 2/3 • Number of events 10 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Blood and lymphatic system disorders neutrophil count decreased	100.0% 3/3 • Number of events 4 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Blood and lymphatic system disorders thrombocytopenia	33.3% 1/3 • Number of events 1 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Blood and lymphatic system disorders leukocytosis	66.7% 2/3 • Number of events 2 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Cardiac disorders atrial fibrillation	33.3% 1/3 • Number of events 1 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Cardiac disorders sinus tachycardia	66.7% 2/3 • Number of events 3 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Cardiac disorders bradycardia	33.3% 1/3 • Number of events 1 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Eye disorders dry eyes	33.3% 1/3 • Number of events 1 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Eye disorders watery eyes	33.3% 1/3 • Number of events 1 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Eye disorders eye redness	33.3% 1/3 • Number of events 1 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Gastrointestinal disorders abdominal pain	33.3% 1/3 • Number of events 2 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Gastrointestinal disorders constipation	33.3% 1/3 • Number of events 1 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Gastrointestinal disorders diarrhea	33.3% 1/3 • Number of events 1 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Infections and infestations clostridium difficile colitis	33.3% 1/3 • Number of events 1 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Gastrointestinal disorders nausea and vomiting	33.3% 1/3 • Number of events 3 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
General disorders fatigue	100.0% 3/3 • Number of events 4 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Respiratory, thoracic and mediastinal disorders hemoptysis	33.3% 1/3 • Number of events 2 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Infections and infestations pneumonia	33.3% 1/3 • Number of events 1 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Respiratory, thoracic and mediastinal disorders shortness of breath	33.3% 1/3 • Number of events 2 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Blood and lymphatic system disorders epistaxis	33.3% 1/3 • Number of events 2 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Metabolism and nutrition disorders hyponatremia	33.3% 1/3 • Number of events 1 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Metabolism and nutrition disorders hypocalcemia	33.3% 1/3 • Number of events 1 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Metabolism and nutrition disorders hyperkalemia	33.3% 1/3 • Number of events 1 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Metabolism and nutrition disorders anorexia	66.7% 2/3 • Number of events 4 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Renal and urinary disorders elevated creatinine	33.3% 1/3 • Number of events 2 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Metabolism and nutrition disorders acidosis	66.7% 2/3 • Number of events 2 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Renal and urinary disorders hematuria	33.3% 1/3 • Number of events 1 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Musculoskeletal and connective tissue disorders myalgia	33.3% 1/3 • Number of events 1 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Cardiac disorders hypotension	66.7% 2/3 • Number of events 2 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Cardiac disorders hypertension	33.3% 1/3 • Number of events 3 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment
Gastrointestinal disorders mucositis	66.7% 2/3 • Number of events 2 • Up to a maximum of 12 months. Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment

Additional Information

Dr. Roger Keresztes

Stony Brook University

Phone: 631-638-1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place