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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

StatusRecruiting
PhasePhase 3
SponsorPfizer
Started2026-01-06
View on ClinicalTrials.gov ↗

Amendment history

2026-09-26
minor
Trial sites expanded: 440 → 479 locations
2026-08-14
minor
Study Status, Contacts/Locations v8
Trial sites expanded: 413 → 440 locations
2026-07-21
minor
Study Status, Contacts/Locations v7
Trial sites expanded: 373 → 413 locations
2026-07-07
minor
Study Status, Contacts/Locations v6
Trial sites expanded: 346 → 373 locations
2026-06-03
minor
Study Status, Contacts/Locations v5
Trial sites expanded: 251 → 346 locations
2026-05-19
minor
Study Identification, Study Status, Contacts/Locations v4
Trial sites expanded: 229 → 251 locations
2026-04-17
minor
Study Status, Contacts/Locations v3
Trial sites expanded: 153 → 229 locations
2026-04-02
minor
Study Identification, Study Status, Outcome Measures, Contacts/Locations v2
Trial sites expanded: 17 → 153 locations
Secondary endpoints13 entries, revised
[...] of life (QoL) and physical function scores on the European OrganisationOrganization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Study title+20 characters
Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 [...]
2026-01-22
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Design, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-12-05→confirmed 2026-01-06
Enrollment target1500→1410
Study sites0→17
Secondary endpoints13 entries, revised
Mean scores and Change from baseline in the global health status/quality of life (QoL) scoreand physical function scores on the European Organisation for Research and Treatment of [...] ive deterioration (TTdD) in in the global health status/QoL scoreand physical function scores on the EORTC QLQ-C30
2025-10-28
minor
Original filing
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.
Trial Details
NCT Number NCT07222566
Lead Sponsor Pfizer
Conditions Advanced Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung, Carcinoma, Non-Small-Cell Lung (NSCLC), Metastatic Non Small Cell Lung Cancer, Lung Cancer
Enrollment 1,410 participants
Start Date 2026-01-06
Primary Completion 2029-02-27 (estimated)
Study Completion 2032-08-26 (estimated)
Updated on ClinicalTrials.gov 2026-09-25