Ramucirumab for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Non-Small Cell Lung Cancer+3 MoreRamucirumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying ramucirumab and pembrolizumab to see how well they work compared to standard of care in treating patients with non-small cell lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Stage IVA Lung Cancer
  • Stage IV Lung Cancer
  • Stage IVB Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 3 years

Year 3
Duration of response (DOR)
Year 3
Investigator assessed-progression-free survival (IA-PFS)
Up to 3 years
Incidence of adverse events
Overall survival (OS)
Response rates (RR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm A (docetaxel, gemcitabine, ramucirumab, pemetrexed)
1 of 2
Arm B (ramucirumab, pembrolizumab)
1 of 2

Active Control

Experimental Treatment

166 Total Participants · 2 Treatment Groups

Primary Treatment: Ramucirumab · No Placebo Group · Phase 2

Arm B (ramucirumab, pembrolizumab)Experimental Group · 2 Interventions: Ramucirumab, Pembrolizumab · Intervention Types: Biological, Biological
Arm A (docetaxel, gemcitabine, ramucirumab, pemetrexed)ActiveComparator Group · 6 Interventions: Pemetrexed, Gemcitabine Hydrochloride, Ramucirumab, Gemcitabine, Docetaxel, Pemetrexed Disodium · Intervention Types: Drug, Drug, Biological, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ramucirumab
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,071 Previous Clinical Trials
41,128,689 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
386 Previous Clinical Trials
261,487 Total Patients Enrolled
Karen L ReckampPrincipal InvestigatorSouthwest Oncology Group
1 Previous Clinical Trials
700 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had at least one grade 3 or worse irAE.
Patients must not have an active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
Patients must have been assigned to S1800A by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC).
You have had prior anti-PD-1/PD-L1 immunotherapy for at least 2 years.
Exception to the above: Toxicities of any grade that requires replacement therapy and has stabilized on therapy (e.g.
You have no history of organ transplant that requires use of immunosuppressants.