PF-08634404 with Chemotherapy for Small Cell Lung Cancer
Symbiotic-Lung-04: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Extensive-Stage Small Cell Lung Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
550 (estimated)
Sponsor
Pfizer · Industry
Who this trial is looking for
This trial is looking for adults with extensive-stage small cell lung cancer who have not yet received chemotherapy or radiation. Participants will receive a new medicine called PF-08634404 along with chemotherapy to see how well it works.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older
I have extensive-stage small cell lung cancer confirmed by lab tests
I have not received chemotherapy or radiation for this type of lung cancer
I am in good physical condition and have healthy organs
I have at least one measurable lesion
I have a performance status of 0 or 1
You may not be able to join if
I have known active brain or spinal cord cancer
I have leptomeningeal disease
I have a significant risk of bleeding or fistula
I have had another cancer in the past 3 years
I have an active autoimmune disease requiring treatment in the past 2 years
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 extensive-stage small cell lung cancer (ES-SCLC), a fast-growing type of lung cancer that has spread widely in the body.
To join the study, participants must meet the following conditions:
* Be 18 years or older.
* Have extensive-stage small cell lung c…
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 extensive-stage small cell lung cancer (ES-SCLC), a fast-growing type of lung cancer that has spread widely in the body.
To join the study, participants must meet the following conditions:
* Be 18 years or older.
* Have extensive-stage small cell lung cancer confirmed by lab tests.
* Have not received chemotherapy or radiation for this type of lung cancer.
* Be in good physical condition and have healthy organs based on medical tests.
The study has two parts:
* In the first part, researchers will check how safe the study medicine is and how well people tolerate it when given with chemotherapy.
* In the second part, they will compare study medicine plus chemotherapy to another approved treatment (atezolizumab plus chemotherapy) to see which works better.
Participants will receive the treatment through IV infusions (medicine given directly into a vein). The treatment will be given in repeated time periods called cycles. Some participants will continue receiving the study medicine alone after the initial treatment.
Trial Locations
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Facility
City
State
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Status
Eligibility Criteria
Inclusion Criteria:
* Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
* Participants have not received systemic therapy (chemotherapy, radiotherapy, chemoradiation) for ES-SCLC.
* Treatment-free for at least 6 months since last chemo/radiotherapy, among t…
Inclusion Criteria:
* Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
* Participants have not received systemic therapy (chemotherapy, radiotherapy, chemoradiation) for ES-SCLC.
* Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
* Have at least one measurable lesion as the targeted lesion based on RECIST V1.1.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Adequate organ function
Exclusion Criteria:
* known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression
* Leptomeningeal disease
* Clinically significant risk of hemorrhage or fistula
* history of another malignancy within 3 years
* active autoimmune diseases requiring systemic treatment within the past 2 years
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