About this trial

This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab) versus immunotherapy alone in treating patients with stage IIIB-IV lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and chemotherapy may help stabilize lung cancer.

Eligibility criteria

Qualifiers

STEP 1 REGISTRATION

Patient must be ≥ 70 years of age

Patient must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with PD-L1 Tumor Proportion Score (TPS) range of 1-49%

Patient must have Stage IIIB, IIIC or IV disease and not be candidates for combined chemo-radiation. NOTE: Prior chemo-radiation therapy (RT) for stage III with recurrence is allowed

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Carboplatin
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Nab-paclitaxel
  • Paclitaxel
  • Pembrolizumab
  • Pemetrexed
  • Positron Emission Tomography
  • Questionnaire Administration

Treatment groups

304 Participants
are divided into 2 treatment groups

Locations

319
Arkansas
Highlands Oncology Group - Fayetteville72703, Fayetteville United States
Mercy Hospital Fort Smith72903, Fort Smith United States
Highlands Oncology Group - Rogers72758, Rogers United States
Highlands Oncology Group72762, Springdale United States

Sponsors and collaborators

National Cancer Institute (NCI)

Lead sponsor