Study on PF-08634404 with Chemotherapy for Adults with Transformed Small Cell Lung Cancer
Sponsor: Pfizer
ClinicalTrials ID:NCT07476287
This clinical trial is exploring a new medicine, PF-08634404, to see how well it works alone and with chemotherapy in adults with Transformed Small Cell Lung Cancer (T-SCLC), a rare type of lung cancer that becomes more aggressive after treatment stops working.
Patient Parameters
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Program Overview
The study aims to learn more about a new medicine called PF-08634404 and how effective it is when used alone or with chemotherapy in treating Transformed Small Cell Lung Cancer (T-SCLC). T-SCLC is a rare form of lung cancer that occurs when a previous type of lung cancer changes into a more aggressive form after treatment stops working. Participants will receive chemotherapy along with the study medicine, followed by the study medicine alone. Treatments will be given through IV infusions at clinical study sites, where medical staff will monitor participants during and after each visit.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 years or older.
- Diagnosed with Transformed Small Cell Lung Cancer (T-SCLC) after having non-small cell lung cancer with an EGFR mutation treated with TKIs.
- Have not received treatment for T-SCLC, except possibly one cycle of chemotherapy.
- Have at least one measurable tumor based on standard criteria.
- Have enough tumor tissue available from the T-SCLC diagnosis.
- Be in good physical condition with a performance status of 0 or 1.
- Have a life expectancy of more than 12 weeks.
- Have acceptable blood test results for blood cells, liver, and kidney function.
Exclusion Criteria
- Have active or untreated cancer in the brain, spinal cord, or surrounding areas, unless stable and treated.
- Have leptomeningeal disease (cancer in the membranes covering the brain and spinal cord).
- Have a high risk of bleeding or fistula (abnormal connection between organs).
- Have had another cancer (besides NSCLC) within the last 3 years, except for certain low-risk cancers.
- Have unresolved side effects from previous cancer treatments.
- Have had an organ or stem cell transplant.
- Have an active autoimmune disease needing treatment in the past 2 years.
- Have lung diseases like interstitial lung disease or severe asthma.
- Have uncontrolled heart, brain, metabolic, liver, or kidney disease.
- Have a prolonged QT interval on an ECG.
- Have had major surgery or severe injury recently.
- Have significant fluid buildup around the lungs, heart, or abdomen.
- Have a history of bleeding disorders or recent major bleeding.
- Have serious gastrointestinal issues like perforation or active bleeding.
- Have active, uncontrolled infections like TB, hepatitis B or C, or HIV.
- Have a history of immune system problems.
- Have severe allergies to study drugs or antibodies.
- Have psychiatric conditions that may interfere with the study.
- Have used certain prohibited medications or treatments recently.
- Are pregnant, breastfeeding, or not willing to use contraception.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope National Medical Center | 91010 | Duarte | California |
| City of Hope Lennar Foundation Cancer Center | 92618 | Irvine | California |
| Hope and Healing Clinical Research | 60521 | Hinsdale | Illinois |
| Hope and Healing Clinical Research | 60451 | New Lenox | Illinois |
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