40 Participants NeededMy employer runs this trial

PF-08634404 + Chemotherapy for Small Cell Lung Cancer

Recruiting at 29 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effectiveness of a new medicine, PF-08634404 (an experimental treatment), for people with Transformed Small Cell Lung Cancer (T-SCLC). The trial will assess the medicine's efficacy both alone and in combination with chemotherapy, which kills or stops cancer cell growth. Individuals with T-SCLC who previously had a specific type of lung cancer treated with targeted pills and have not yet received treatment for T-SCLC may be suitable candidates for this trial. Participants will receive treatments through IV infusions, with a medical team closely monitoring them. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, certain medications like high-dose systemic corticosteroids, specific anticoagulants, or live vaccines are prohibited within specific timeframes. It's best to discuss your current medications with the study team.

Is there any evidence suggesting that PF-08634404 is likely to be safe for humans?

Earlier studies have shown that PF-08634404 is safe when used alone or with chemotherapy. Research indicates that patients generally tolerated the treatment well. So far, no major safety issues have emerged. For those considering joining a trial, this suggests that while some side effects might occur, they are usually manageable. Discuss any concerns with the medical team conducting the trial.12345

Why do researchers think this study treatment might be promising for small cell lung cancer?

Unlike the standard chemotherapy treatments for small cell lung cancer, PF-08634404 offers a unique approach by combining with chemotherapy and then continuing as a maintenance therapy. This new drug potentially enhances the effectiveness of chemotherapy by providing ongoing treatment rather than just during initial cycles. Researchers are excited about PF-08634404 because it may target cancer cells more consistently, potentially leading to better long-term outcomes for patients with this aggressive type of lung cancer.

What evidence suggests that PF-08634404 might be an effective treatment for T-SCLC?

Research suggests that PF-08634404, a new treatment tested in this trial, shows promise when combined with chemotherapy for small cell lung cancer (SCLC). Other studies have shown encouraging results in slowing cancer growth and consider it safe when used alone in similar situations. PF-08634404 targets two proteins, PD-1 and VEGF, which help cancer cells evade the immune system and grow new blood vessels. These early findings offer hope that PF-08634404 could effectively treat transformed small cell lung cancer (T-SCLC), but further research is needed to confirm these effects.12367

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults (18+) with transformed small cell lung cancer (T-SCLC) that developed from EGFR-mutated non-small cell lung cancer after TKI treatment. Participants must be in good health, have not received prior treatment for T-SCLC (except possibly one chemo cycle), and meet specific lab and organ function requirements.

Inclusion Criteria

Clinical laboratory values at screening within acceptable limits for Hematology, Liver function, and Renal function
Have a minimum life expectancy of >12 weeks
I have enough tumor tissue from my transformed SCLC diagnosis available.
See 5 more

Exclusion Criteria

I have cancer that has spread to the lining of my brain or spinal cord.
I have not had another cancer (besides NSCLC) in the past 3 years.
Baseline QTcF >480 msec
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Combination Treatment

Participants receive PF-08634404 in combination with chemotherapy through IV infusions

Approximately 1 year
Regular visits at clinical study sites

Maintenance Therapy

Participants continue with PF-08634404 alone after combination treatment

Up to 1 year
Regular visits at clinical study sites

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 90 days after the last dose

Long-term Follow-up

Participants are monitored for overall survival and progression-free survival

Up to approximately 2 years after completion of study treatment

What Are the Treatments Tested in This Trial?

Interventions

  • PF-08634404

Trial Overview

The study tests a new medicine called PF-08634404 given with chemotherapy through IV infusions to see how well it works for T-SCLC. After the initial combination phase, participants continue on PF-08634404 alone. All treatments are monitored at clinical sites.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: PF-08634404Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

NCT07226999 | Symbiotic-Lung-04: A Study to Learn ...

This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to adults with ...

440TiP A phase II/III trial of a PD-1/VEGF bispecific ...

This study will evaluate the outcomes of PF-08634404 in combination with chemotherapy in extensive-stage small cell lung cancer (ES-SCLC). Trial design.

PD-1 x VEGF Bispecific Antibody

PD-1 x VEGF Bispecific Antibody. PF-08634404 is an investigational compound. Its safety and efficacy have not been established.

1328 SSGJ-707, a PD-1/VEGF bispecific antibody ...

Results from a phase 2 study demonstrated promising efficacy and manageable safety as monotherapy in first-line NSCLC with tumor proportion ...

Phase II/III Trial of PD-1/VEGF Antibody in Small Cell Lung ...

This study examines the effectiveness and safety of a new treatment approach combining PF-08634404, a bispecific antibody targeting PD-1 (a ...

Clinical Trial for Small Cell Lung Cancer (SCLC).

This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to adults with ...

NCT07476287 | Symbiotic-Lung-14: A Study to Learn ...

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 ...