Phase II Study of New Cancer Treatments for NSCLC Patients Who Didn't Respond to Anti-PD-1/PD-L1 Therapy
Sponsor: AstraZeneca
ClinicalTrials ID:NCT03334617
This clinical trial is exploring new treatments for patients with advanced non-small cell lung cancer (NSCLC) that has continued to grow despite previous treatments, including anti-PD-1/PD-L1 therapy. The study aims to evaluate the effectiveness and safety of various new treatment options.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is designed to test new treatments for patients with advanced non-small cell lung cancer (NSCLC) that has not responded to previous therapies, including anti-PD-1/PD-L1 treatments. The study will take place at multiple centers and will include different treatment groups to assess how well these new treatments work and how safe they are. There is currently no standard treatment for patients who have already tried immune checkpoint inhibitors and platinum-based chemotherapy, so this study is important for finding new options.
Description
This Phase II study is open to patients with advanced non-small cell lung cancer (NSCLC) that has continued to progress despite treatment with anti-PD-1/PD-L1 therapies and platinum-based chemotherapy. The study is structured to include multiple treatment groups, allowing researchers to evaluate the effectiveness and safety of several new treatment options. Since there is no established treatment for patients who have already received these therapies, the study aims to find new and effective treatments. The study's design allows for the addition of new treatment groups in the future as more options become available.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) that is worsening.
- Eligible for second or later lines of therapy, having previously received anti-PD-1/PD-L1 therapy and platinum-based chemotherapy.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities, and a life expectancy of at least 12 weeks.
- Have at least one tumor that can be measured accurately. Tumors that have been treated with radiation can be included if they have grown since treatment.
- Women must be post-menopausal or have a negative pregnancy test if pre-menopausal.
Exclusion Criteria
- Tumors with specific genetic changes that can be targeted by other treatments, such as EGFR, ALK, ROS1, BRAF, MET, or RET mutations.
- Have active or previously diagnosed autoimmune or inflammatory disorders.
- Have active infections like tuberculosis, hepatitis B or C, or HIV.
- Women who are pregnant or breastfeeding, or individuals not using effective birth control.
- Known allergies to any of the study drugs or their ingredients.
- Have spinal cord compression or symptomatic brain metastases.
- Currently receiving other cancer treatments, except for bone-strengthening medications.
- History of primary immune system deficiencies.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 91010 | Duarte | California |
| Research Site | 92835 | Fullerton | California |
| Research Site | 92093 | La Jolla | California |
| Research Site | 90095 | Los Angeles | California |
| Research Site | 20016 | Washington D.C. | District of Columbia |
| Research Site | 60637 | Chicago | Illinois |
| Research Site | 21224 | Baltimore | Maryland |
| Research Site | 21287 | Baltimore | Maryland |
| Research Site | 02215 | Boston | Massachusetts |
| Research Site | 63110 | St Louis | Missouri |
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