Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult Participants With Transformed Small Cell Lung Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
Pfizer
Study ID
NCT07476287
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PF-08634404 — DRUG
    Concentrate for solution for infusion
  • Chemotherapy — DRUG
    Injection for intravenous use

Study Details

This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well PF-08634404 works when given alone or with chemotherapy . Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells or stop them from growing. The study is for adults with Transformed Small Cell Lung Cancer (T-SCLC ). T SCLC is a rare lung cancer that happens when one type of lung cancer changes into a more aggressive type after treatment stops working. To join the study, participants must meet the following conditions: * Are aged 18 years or older * Diagnosed with T-SCLC and have not received treatment for this type of lung cancer (a single cycle of chemotherapy may be permitted) * Prior diagnosis of epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer treated with tyrosine kinase inhibitors (TKIs) * Have healthy organs based on medical tests and are in good physical condition After joining the study, adults will be given chemotherapy in addition to the study medicine. After this combination treatment is finished, the study medicine will be continued alone. Adults will receive the treatment through IV infusions (medicine given directly into a vein). All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.

Key Dates

Start date
May 15, 2026
Status verified
Jun 2026
Primary completion
Mar 19, 2028
Completion
Mar 19, 2031

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PF-08634404
    Participants will receive PF-08634404 in combination with chemotherapy intravenously, followed by maintenance therapy with PF-08634404.

Primary Outcome Measure

Confirmed Objective Response Rate (ORR) as assessed by investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) [ Time Frame: From start of treatment until first documented CR or PR (approximately maximum up to 1 years) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
City of Hope Lennar Foundation Cancer CenterIrvineCalifornia92618-
Hope and Healing Clinical ResearchHinsdaleIllinois60521-
Hope and Healing Clinical ResearchNew LenoxIllinois60451-

Find similar trials in Duarte, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
City of Hope National Medical Center· Duarte, CACity of Hope Lennar Foundation Cancer Center· Irvine, CAHope and Healing Clinical Research· Hinsdale, ILHope and Healing Clinical Research· New Lenox, IL

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