Local Consolidation Therapy for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Non-Small Cell Lung Cancer+2 MoreLocal Consolidation Therapy - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether adding immunotherapy to standard local consolidation therapy can improve outcomes for patients with stage IV non-small cell lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Lung Adenocarcinoma
  • Stage IV Lung Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Up to 1 year after completion of study treatment

Year 1
OS in oligometastatic subgroup
Overall survival (OS) in overall population

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Arm A (ipilimumab, nivolumab)
1 of 2
Arm B (ipilimumab, nivolumab, LCT)
1 of 2

Experimental Treatment

360 Total Participants · 2 Treatment Groups

Primary Treatment: Local Consolidation Therapy · No Placebo Group · Phase 3

Arm A (ipilimumab, nivolumab)Experimental Group · 3 Interventions: Nivolumab, Quality-of-Life Assessment, Ipilimumab · Intervention Types: Biological, Other, Biological
Arm B (ipilimumab, nivolumab, LCT)Experimental Group · 6 Interventions: Therapeutic Conventional Surgery, Radiation Therapy, Nivolumab, Quality-of-Life Assessment, Ipilimumab, Local Consolidation Therapy · Intervention Types: Procedure, Radiation, Biological, Other, Biological, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Conventional Surgery
2005
Completed Phase 3
~8410
Radiation Therapy
2005
Completed Phase 3
~7010
Nivolumab
FDA approved
Ipilimumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year after completion of study treatment

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,802 Previous Clinical Trials
1,788,543 Total Patients Enrolled
John V HeymachPrincipal InvestigatorM.D. Anderson Cancer Center
John V Heymach, MD, PHDPrincipal InvestigatorM.D. Anderson Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Stage IV cancer is cancer that has spread from where it first started to other parts of the body.
The patient agrees to take part in the study and has been given all the relevant information about the study
The patient has a performance status of 0 or 1 if using the Eastern Cooperative Oncology Group (ECOG)/Zubrod scale.
Patients with metastatic cancer are allowed to receive one prior line of chemotherapy and/or targeted agents
Patients with non-small cell lung cancer that has been confirmed by histology or cytology are eligible for this study
The patient must have a white blood cell count of at least 2000 cells per microliter within 14 days prior to randomization or registration.
Neutrophils must be at least 1500/uL (obtained within 14 days prior to randomization/registration).
You must have a platelet count of at least 100,000 per microliter of blood (obtained within the past 14 days) in order to be eligible for this study.
A person's hemoglobin level must be 9.0 g/dL or higher within 14 days of the study in order to participate.