A PHASE 2 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY UNTREATED TRANSFORMED SMALL CELL LUNG CANCER

Plain English Summary

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 is a Phase 2 clinical trial sponsored by Pfizer studying Small Cell Lung Cancer, Small Cell Lung Cancer ( SCLC ), Transformed Small Cell Lung Cancer, Lung Neoplasms, Carcinoma, Small Cell Lung, Small Cell Cancer Of The Lung. This study tests a new drug, PF-08634404, combined with chemotherapy for a specific type of lung cancer. It is for adults with transformed small cell lung cancer (T-SCLC) that has changed after initial treatment. Participants will receive the study drug and chemotherapy via IV, followed by the study drug alone. Alternative treatments may include other chemotherapy regimens or targeted therapies depending on the specific cancer characteristics. The trial aims to enroll 40 participants.

Official Summary

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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with transformed small cell lung cancer. Must have had a prior diagnosis of EGFR-mutated non-small cell lung cancer treated with specific drugs. Cannot have received prior treatment for their transformed small cell lung cancer (a single cycle of chemotherapy might be allowed). Must have healthy organs and be in good physical condition, with no active or untreated brain metastases. This trial is studying Small Cell Lung Cancer, Small Cell Lung Cancer ( SCLC ), Transformed Small Cell Lung Cancer, Lung Neoplasms, Carcinoma, Small Cell Lung, Small Cell Cancer Of The Lung, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The study will measure how many patients respond to the new drug combination by seeing if their tumors shrink or disappear, indicating the treatment is working. The specific primary outcome measures are: Confirmed Objective Response Rate (ORR) as assessed by investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) (From start of treatment until first documented CR or PR (approximately maximum up to 1 years)); Number of Participants with Adverse Events (AEs) (Up to 90 days after the last dose of treatment). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a critical need for new treatments in transformed small cell lung cancer, a rare and aggressive form of lung cancer that has progressed after initial therapy. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Small Cell Lung Cancer, Small Cell Lung Cancer ( SCLC ), Transformed Small Cell Lung Cancer, Lung Neoplasms, Carcinoma, Small Cell Lung, Small Cell Cancer Of The Lung, where improved treatment options are needed.

Investor Insight

This trial represents Pfizer's effort to develop new therapies for a challenging lung cancer subtype, potentially opening a new treatment avenue in a market with significant unmet needs. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if this study is right for you, especially regarding your specific cancer history and previous treatments. Participation involves regular IV infusions of the study drug and chemotherapy at a clinical site, with close monitoring by a medical team. Day-to-day life may involve managing potential side effects and attending scheduled appointments for treatment and assessments. This trial is currently recruiting participants. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 40 participants

Interventions

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

Primary Outcomes

• Confirmed Objective Response Rate (ORR) as assessed by investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) (From start of treatment until first documented CR or PR (approximately maximum up to 1 years))
• Number of Participants with Adverse Events (AEs) (Up to 90 days after the last dose of treatment)

Secondary Outcomes

• Duration of Response (DOR) as assessed by investigator based on RECIST v1.1 (Up to approximately 2 years after completion of study treatment of last study participant)
• Progression Free Survival (PFS) as assessed by investigator based on RECIST v1.1 (Up to approximately 2 years after completion of study treatment of last study participant)
• Overall Survival (OS) (Up to approximately 2 years after completion of study treatment of last study participant)
• Number of participants with Laboratory abnormalities (Up to 90 days after the last dose of treatment)
• Pharmacokinetics: Predose and postdose Serum concentrations of PF-08634404 (Up to 37 days after the last dose of treatment)

Full Eligibility Criteria

Inclusion Criteria:

* Male or female participants aged ≥18 years at the time of informed consent.
* Histologically or cytologically confirmed T-SCLC. Participant must have had a prior diagnosis of NSCLC with EGFR mutation which transformed to SCLC following the treatment with TKI(s).
* Participants have not received systemic therapy for T-SCLC.
* Have at least one measurable lesion as the target lesion based on RECIST v1.1.
* Have sufficient tumor tissue from the diagnosis of transformed SCLC available.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Have a minimum life expectancy of \>12 weeks.
* Clinical laboratory values at screening within acceptable limits, as defined in the protocol, including: 1) Hematology, 2) Liver function and 3) Renal function.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Active or untreated CNS disease, including brain, brainstem, spinal cord, or meningeal metastases. Participants with definitively treated, clinically stable brain metastases may be eligible per protocol criteria. Participants with untreated asymptomatic brain metastases of longest diameter \<1 cm are permitted if all of the following criteria are met: absence of neurological symptoms, no need for corticosteroids, and brain metastasis has no evidence of edema or hemorrhagic features.
* Leptomeningeal disease
* Clinically significant risk of hemorrhage or fistula, including tumor necrosis/cavitation, invasion or compression of major blood vessels, airways, or critical organs, or risk of tracheoesophageal or pleuroesophageal fistula
* History of another malignancy (other than NSCLC) within 3 years prior to first dose, except for malignancies with negligible risk of metastasis or death (eg, adequately treated carcinoma in situ, nonmelanoma skin cancer)
* Unresolved toxicity from prior anti-tumor therapy that has not recovered to Grade ≤1 per NCI CTCAE v5.0 (except alopecia or irreversible toxicities deemed stable)
* History of allogeneic organ or hematopoietic stem cell transplantation
* Active autoimmune disease requiring systemic treatment within the past 2 years (Stable replacement therapy and selected low-risk autoimmune conditions are permitted per protocol)
* Interstitial lung disease (ILD), pneumonitis, or significant pulmonary disease, including:

  * Prior or current non-infectious pneumonitis requiring systemic therapy
  * DLCO \<50% predicted
  * Severe asthma, COPD, pulmonary embolism, or autoimmune lung involvement
* Uncontrolled or clinically significant cardiovascular, cerebrovascular, metabolic, hepatic, or renal disease within 6 months prior to first dose
* Baseline QTcF \>480 msec
* Major surgery or severe trauma within 4 weeks prior to first dose, or planned major surgery during the study
* Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage
* History of significant bleeding disorders or recent major bleeding events
* Clinically significant gastrointestinal conditions, including recent perforation, fistula, obstruction, or active bleeding
* Active, uncontrolled, or symptomatic infection, including:

  * Active TB
  * Active hepatitis B or C
  * Uncontrolled HIV infection
* History of immunodeficiency
* Severe hypersensitivity or allergic reactions to study intervention components or monoclonal antibodies
* Psychiatric illness or medical condition, including recent suicidal ideation or behavior, that may increase risk or interfere with study participation
* Prior anti-angiogenic therapy or other prohibited anti-tumor or immunomodulatory therapies per protocol-specified washout periods
* Use of prohibited concomitant medications, including high-dose systemic corticosteroids, certain anticoagulants, or live vaccines within protocol-specified timeframes
* Recent participation in another investigational study (within 30 days or 5 half-lives, whichever is longer)
* Pregnant or breastfeeding participants, or unwillingness to comply with contraception requirements

Trial Locations

• Hope and Healing Clinical Research, Hinsdale, Illinois, United States
• Hope and Healing Clinical Research, New Lenox, Illinois, United States

Frequently Asked Questions

Related Conditions

• Small Cell Lung Cancer
• Transformed Small Cell Lung Cancer
• Non-Small Cell Lung Cancer
• EGFR-mutated Lung Cancer
• Lung Neoplasms
• Carcinoma, Small Cell Lung
• Chemotherapy
• Targeted Therapy
• Oncology
• Cancer Treatment

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