🏛️ Verified NIH Record • Updated 2026-08-14

Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NCT07222566)

AN INTERVENTIONAL PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Pfizer

🩺 Plain-English Summary (8th-Grade Level)

This study is being done to find out if a new medicine called PF-08634404, when given with chemotherapy, works better than the present standard treatment (pembrolizumab with chemotherapy) for adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC. * Is not a candidate for complete surgical resection or curative chemoradiotherapy. * Do not have known actionable genomic alterations * Be treatment naïve for advanced or metastatic disease Participants in this study will be assigned to two different parts of the study depending on their type of tumor: participants with squamous NSCLC will be assigned to Part 1, while participants with non-squamous NSCLC will be assigned to Part 2. Each participant will be randomly assigned (like a flip of the coin) to one of two treatment groups in a blinded fashion: * Part 1 - Arm A or Part 2 - Arm C (Experimental Group): Will receive a new study medicine called PF-08634404 along with a kind of chemotherapy specific to the type of tumor. * Part 1 - Arm B or Part 2 - Arm D (Control Group): Will receive an approved medicine called pembrolizumab along with a kind of chemotherapy specific to the type of tumor. Participants will receive their assigned treatment through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, participants will receive PF-08634404 or Pembrolizumab in combination with chemotherapy followed by maintenance with either PF-08634404 or Pembrolizumab monotherapy (Part 1) or PF-08634404 or Pembrolizumab in combination with a chemotherapeutic drug (Part 2). Participants will continue receiving treatment if it is helping and not experiencing serious side effects. The study will include regular visits for: * Treatment and health checks: while participant continues receiving treatment. * Tests to monitor how cancer responds: every 6 weeks during the first 48 weeks, then every 12 weeks thereafter.

Who can join: Review the eligibility criteria below.

Location: Pioneer Research Center — Bullhead City, Arizona

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (440 Sites)

Showing the first 25 of 440 sites.

  • Pioneer Research Center — Bullhead City, Arizona
  • Ironwood Cancer & Research Centers — Chandler, Arizona
  • Ironwood Cancer & Research Centers — Gilbert, Arizona
  • Ironwood Cancer & Research Centers — Glendale, Arizona
  • Ironwood Cancer & Research Centers — Goodyear, Arizona
  • Ironwood Cancer & Research Centers — Mesa, Arizona
  • Ironwood Cancer & Research Centers — Mesa, Arizona
  • Ironwood Cancer & Research Centers — Phoenix, Arizona
  • Ironwood Cancer & Research Centers — Scottsdale, Arizona
  • Highlands Oncology Group — Fayetteville, Arkansas
  • Highlands Oncology Group — Rogers, Arkansas
  • Highlands Oncology Group — Springdale, Arkansas
  • Oncura Health - Anaheim — Anaheim, California
  • Memorial Care Orange Coast Medical Center Attn — Fountain Valley, California
  • MemorialCare Orange Coast Medical Center — Fountain Valley, California
  • OC Blood and Cancer Care — Fountain Valley, California
  • Oncura Health - Fountain Valley — Fountain Valley, California
  • Oncura Health - Corporate (Central IDS & Regulatory Only) — Glendale, California
  • Memorial Care Saddleback Medical Center Attn — Laguna Hills, California
  • MemorialCare Saddleback Medical Center — Laguna Hills, California
  • Stockton Hematology Oncology Medical Group — Lodi, California
  • Memorial Care Long Beach Medical Center — Long Beach, California
  • Oncura Health - Good Samaritan — Los Angeles, California
  • California Research Institute — Los Angeles, California
  • Stockton Hematology Oncology Medical Group — Manteca, California

📞 Contact the Study Coordinator

Phone: (800) 718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗