PF-08634404 + Chemotherapy for Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new medicine, PF-08634404 (an experimental treatment), combined with chemotherapy, to evaluate its effectiveness for people with extensive-stage small cell lung cancer (ES-SCLC), a rapidly spreading type of lung cancer. In the first part, researchers assess the safety of the new medicine with chemotherapy. In the second part, they compare this new treatment to a current one to determine which is more effective. Individuals with this type of lung cancer who haven't received chemo or radiation and are in good health might be suitable for this trial. Participants will receive treatment through IV infusions in cycles, with some continuing the new medicine alone after initial treatment.
As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in cancer treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, since participants must not have received chemotherapy or radiation for this type of lung cancer, it's possible that some medications might need to be paused. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that PF-08634404 is a unique antibody targeting two proteins, PD-1 and VEGF, which aid cancer growth and help it evade the immune system. Previous studies have examined its safety when combined with chemotherapy for lung cancer treatment.
In these studies, PF-08634404 was generally well-tolerated, with most participants not experiencing severe side effects. Common side effects included fatigue, nausea, and changes in blood cell counts, typical of cancer treatments. Importantly, no unexpected or severe side effects have been reported.
This treatment is being compared with another approved treatment, indicating some confidence in its safety. However, as it is in phase 2 and 3 trials, researchers continue to study it closely to ensure its safety and effectiveness for a broader population. Early findings suggest it is promising, but ongoing research is crucial to fully understand its safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about PF-08634404 for small cell lung cancer because it offers a fresh approach compared to existing treatments like chemotherapy combined with atezolizumab. Unlike standard therapies that often target the cancer cells directly, PF-08634404 works by enhancing the immune system's ability to fight cancer, potentially leading to more effective and longer-lasting responses. This new mechanism of action could provide patients with better outcomes and fewer side effects, making it a promising addition to the current treatment landscape.
What evidence suggests that this trial's treatments could be effective for extensive-stage small cell lung cancer?
Research shows that PF-08634404 is a promising new drug targeting two proteins, PD-1 and VEGF, involved in cancer growth. Previous studies have found that drugs targeting these proteins can slow tumor growth and improve survival rates in various cancers. In this trial, participants in the experimental arms will receive PF-08634404 with chemotherapy. Early results suggest that this combination may boost the body's immune response against cancer cells. Meanwhile, participants in the control arm will receive atezolizumab with chemotherapy. The trial aims to determine if the PF-08634404 combination is more effective than standard chemotherapy alone. However, more research is needed to confirm its effectiveness in treating extensive-stage small cell lung cancer (ES-SCLC).12346
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
Adults with extensive-stage small cell lung cancer who haven't had chemo or radiation for it can join this trial. They must be over 18, have a certain level of physical fitness, and healthy organs. Those previously treated for limited-stage SCLC need to have been treatment-free for at least 6 months.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive PF-08634404 in combination with chemotherapy through IV infusions in repeated cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Some participants may continue receiving the study medicine alone after the initial treatment
What Are the Treatments Tested in This Trial?
Interventions
- Atezolizumab
- PF-08634404
Trial Overview
The study is testing PF-08634404 combined with chemotherapy against the approved Atezolizumab plus chemotherapy in adults with ES-SCLC. It's given through IV infusions in cycles, some may continue just the study medicine after initial cycles.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Participants will receive PF-08634404 in combination with chemotherapy
Participants will receive PF-08634404 in combination with chemotherapy
Participants will receive atezolizumab in combination with chemotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Citations
NCT07226999 | A Study to Learn About the ...
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 ...
1328 SSGJ-707, a PD-1/VEGF bispecific antibody ...
Background SSGJ-707 (PF-08634404) is a fully human immunoglobulin G4 bispecific antibody that targets programmed death 1 (PD-1) and vascular ...
3.
s206.q4cdn.com
s206.q4cdn.com/795948973/files/doc_events/2025/Nov/10/PfizerPflash_-4404-SITC-IR-Event-2025_FINAL.pdfPfizer Pflash: A Spotlight on the PF'4404 (SSGJ-707 / PF ...
Epidemiology data are rounded, and sourced from US CancerMPact Patient Metrics, Oracle (2025), includes total incident and newly recurrent ...
NCT07222566 | A Study to Learn About the ...
This study is being done to find out if a new medicine called PF-08634404, when given with chemotherapy, works better than the present ...
5.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/PFE/pressreleases/37022575/pfizer-advances-new-lung-cancer-combo-in-global-phase-23-trial-what-investors-should-watch/Pfizer Advances New Lung Cancer Combo in Global ...
The study aims to see how well a new drug, PF-08634404, works and how safe it is when given with standard chemotherapy in adults with extensive- ...
6.
pfizerclinicaltrials.com
pfizerclinicaltrials.com/find-a-trial/nct07227298-advancedmetastatic-non-small-cell-lung-cancer-trialAdvanced/Metastatic Non-Small Cell Lung Cancer ...
The study will look at: Whether PF-08634404 is safe to use with other cancer medicines. What side effects may happen. A side effect is anything the ...
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