Study on Pembrolizumab With or Without Chemotherapy for Patients Aged 70 and Older With Advanced Non-Small Cell Lung Cancer
Sponsor: Alliance for Clinical Trials in Oncology
ClinicalTrials ID:NCT04533451
This clinical trial is exploring the effects of pembrolizumab, an immunotherapy drug, with or without chemotherapy, in treating older adults with advanced non-small cell lung cancer that has returned or spread. The study aims to understand the side effects and effectiveness of these treatments in shrinking tumors.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is investigating how pembrolizumab, an immunotherapy drug, works alone or with chemotherapy in patients aged 70 and older who have advanced non-small cell lung cancer (NSCLC) that has come back or spread. Pembrolizumab helps the immune system attack cancer cells, while chemotherapy drugs like pemetrexed and carboplatin stop cancer cells from growing and spreading. The goal is to see if these treatments can reduce tumor size in older patients.
Description
The study has two main goals:
Primary Goal:
- To understand the side effects of pembrolizumab in patients aged 70 and older with advanced non-small cell lung cancer, whether used alone or with chemotherapy.
Secondary Goals:
- To estimate how long patients live after treatment.
- To assess patients' quality of life during treatment using a questionnaire.
- To explore if a special assessment for older adults can predict severe side effects from the treatment.
Participants are divided into two groups:
Group A: Patients receive pembrolizumab through an IV for 30 minutes on the first day of each cycle. The cycles repeat every 21 days unless the disease worsens or side effects become unacceptable.
Group B: Patients receive pembrolizumab, pemetrexed, and carboplatin through an IV on the first day of each cycle. The cycles repeat every 21 days unless the disease worsens or side effects become unacceptable.
After finishing the treatment, patients will have follow-up visits once a year for up to five years.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with non-small cell lung cancer (adenocarcinoma) that is stage IV or has returned and spread.
- Planning to start pembrolizumab treatment within 14 days of joining the study, with or without chemotherapy.
- The doctor considers pembrolizumab suitable and plans to use one of these treatment schedules:
- Pembrolizumab 200 mg IV every 21 days or 400 mg IV every 42 days.
- Pembrolizumab 200 mg IV or 400 mg IV with carboplatin and pemetrexed (with possible chemotherapy dose reduction).
- Cannot have an autoimmune disorder, organ transplant, or ongoing immunosuppression treatment.
- Any previous cancer treatment must have been completed at least 6 months before joining the study.
- No planned radiation or other cancer treatment for 3 months after joining the study.
- No untreated brain metastases; must be off corticosteroids and without symptoms at registration.
- Blood counts and kidney function must meet specific levels:
- Neutrophil count of at least 1500/mm³.
- Platelet count of at least 100,000/mm³.
- Creatinine level of at least 30 mL/min for pembrolizumab alone, and over 45 mL/min for chemotherapy + pembrolizumab.
- Liver function tests must be within specified limits.
- Must be able to speak and understand English to complete required questionnaires.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
| Kingman Regional Medical Center | 86401 | Kingman | Arizona |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.