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Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC

StatusRecruiting
PhasePhase 2
SponsorPfizer
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial sites expanded: 29 → 37 locations
  2. Minor Study sites: 27 to 29 Eligibility criteria expanded, about 26 words · Secondary endpoints: details revised at 5 of 13 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 5 of 13 entries
  3. Minor Trial sites expanded: 17 → 27 locationsv5
  4. Minor Trial sites expanded: 14 → 17 locationsv4
  5. Minor Trial sites expanded: 3 → 14 locations Start date changed from estimate of Jun 1, 2026 to Jun 30, 2026v3 Show 1 more changeShow less
    • Start date changed from estimate of Jun 1, 2026 to Jun 30, 2026
  6. Notable Recruitment opened Start date: Apr 1, 2026 to Jun 1, 2026 · Trial sites expanded: 0 → 3 locations · Primary completion date: Aug 4, 2028 to Jul 29, 2028 · 1 morev2 Show 4 more changesShow less
    • Start date: Apr 1, 2026 to Jun 1, 2026
    • Trial sites expanded: 0 → 3 locations
    • Primary completion date: Aug 4, 2028 to Jul 29, 2028
    • Completion date: Aug 5, 2031 to Jul 30, 2031
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07489066
Lead Sponsor Pfizer
Conditions Carcinoma, Non-Small-Cell Lung, Lung Cancer (NSCLC), Lung Neoplasms, Carcinoma, Non-Small-Cell Lung (NSCLC), Lung Disease, Non-Small Cell Lung Cancer, Non-small Cell Lung Cancer, Non-squamous +1 more
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov