Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC
Condition(s) studied
Investigational drug(s) / intervention(s)
PF-08634404: Concentrate for solution for infusion
Chemotherapy Regimen 1: Injection for intravenous use
Chemotherapy Regimen 2: Injection for intravenous use
Study summary
This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well it works when given alone or with chemotherapy. The study is for adults with early stage or locally advanced non-small cell lung cancer (NSCLC) that may or may not be removable with surgery.
The study is seeking participants who:
* Are aged 18 years or older
* Have either:
* Early-stage or locally advanced (Stage II or IIIA/B) NSCLC and are a candidate for neoadjuvant therapy, followed by surgical removal of the tumor. Neoadjuvant therapy is a treatment given as a first step to shrink the tumor before surgery.
* Early-stage or locally advanced (Stage II or IIIA/B) NSCLC and are a candidate for adjuvant therapy and did not achieve a pathological complete response (pCR) from approved treatment that was administered before surgery. Adjuvant therapy is an additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. pCR is defined as absence of viable tumor in all surgically removed samples.
* Locally advanced (Stage III) NSCLC that may not be removable with surgery, was treated with concurrent chemoradiotherapy (cCRT), and is a candidate for additional treatment, otherwise known as consolidation therapy. cCRT is chemotherapy and radiation given simultaneously.
* Be in good physical condition and have healthy organs based on medical tests.
* Do not have known actionable changes in DNA
The study has 3 parts and each participant will be assigned to one part by their doctor based on their disease diagnosis:
* Part A will test PF-08634404 given with chemotherapy in the neoadjuvant setting, followed by surgery.
* Part B will test PF-08634404 alone in adults who already were treated with neoadjuvant chemo-immunotherapy, underwent surgery, and did not achieve pCR per tumor tissue pathology analysis. Neoadjuvant chemo-immunotherapy refers to the combination of chemotherapy with immunotherapy per local standard-of-care, given before surgical removal of the tumor.
* Part C will test PF-08634404 alone in adults with unresectable disease who received cCRT and did not have progressive disease. Progressive disease refers to a condition that grows, spreads, or worsens.
All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.
Eligibility
Primary outcome measure(s)
- Number of Participants With Adverse Events (AEs) — Through 90 days after the last dose of study intervention (Part A only: or 90 days after surgery, whichever is later)
AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s). - Part A: Surgical Feasibility Rate — Up to approximately 6 months after first dose
Surgical Feasibility rate is defined by the proportion of participants undergoing surgery and the proportion of participants with wound complications after surgery. - Part A: Pathological Complete Response (pCR) rate per International Association for the Study of Lung Cancer (IASLC) guidelines as assessed by central pathology review — Up to approximately 6 months after first dose
pCR rate by central pathology review is defined as the proportion of participants having pCR as assessed by central pathologist. pCR is defined as the absence of residual tumor in surgical specimens
Trial sites (29)
| Facility | City | Region | Status |
|---|---|---|---|
| Clearview Cancer Institute (Crestwood) | Huntsville | Alabama | Recruiting |
| Clearview Cancer Institute | Huntsville | Alabama | Recruiting |
| Stanford Cancer Institute | Stanford | California | Recruiting |
| Stanford Hospital and Clinics | Stanford | California | Recruiting |
| Stanford Hospital Investigational Drug Services | Stanford | California | Recruiting |
| University Cancer & Blood Center, LLC | Athens | Georgia | Recruiting |
| Hope and Healing Clinical Research | Hinsdale | Illinois | Recruiting |
| Hope and Healing Clinical Research | New Lenox | Illinois | Recruiting |
| Cancer Partners of Nebraska | Lincoln | Nebraska | Recruiting |
| New Mexico Oncology Hematology Consultants, Ltd | Albuquerque | New Mexico | Not Yet Recruiting |
| University of Tennessee Medical Center | Knoxville | Tennessee | Recruiting |
| Western Health-Sunshine & Footscray Hospitals | St Albans | Victoria | Recruiting |
| Beijing Cancer hospital | Beijing | Beijing Municipality | Recruiting |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | Recruiting |
| The Affiliated Cancer Hospital of Shandong First Medical University | Jinan | Shandong | Recruiting |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | Not Yet Recruiting |
| Prince of Wales Hospital | Hong Kong | Hong Kong | Not Yet Recruiting |
| Sourasky Medical Center | Tel Aviv | TELL ABĪB | Recruiting |
| Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii | Wroclaw | Poland | Not Yet Recruiting |
| Pan American Center for Oncology Trials, LLC - Bayamón Office | Bayamón | Puerto Rico | Recruiting |
| Pan American Center for Oncology Trials, LLC - Manati Office | Manati | Puerto Rico | Recruiting |
| Pan American Center for Oncology Trials, LLC - Ponce Office | Ponce | Puerto Rico | Recruiting |
| Hospital Oncologico Dr. Isaac Gonzalez Martinez | Rio Piedras | Puerto Rico | Recruiting |
| Pan American Center for Oncology Trials, LLC - Ciudadela Office | San Juan | Puerto Rico | Recruiting |
| Chung Shan Medical University Hospital | Taichung | Taiwan | Recruiting |
| National Cheng Kung University Hospital | Tainan | Taiwan | Recruiting |
| National Taiwan University Hospital | Taipei | Taiwan | Not Yet Recruiting |
| Taipei Medical University Hospital | Taipei | Taiwan | Recruiting |
| Taipei Veterans General Hospital | Taipei | Taiwan | Recruiting |
More Pfizer trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07489066 on ClinicalTrials.gov ↗ ← All trials in Spain