Clinical trial for Advanced Non-Small Cell Lung Cancer
Official title 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
ClinicalTrials.gov ID: NCT07222566
What this study is testing
What is PF-08634404?
PF-08634404 is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for advanced non-small cell lung cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether PF‑08634404 plus chemotherapy works better than pembrolizumab plus chemotherapy in adults with advanced non‑small cell lung cancer.
- Who it's for
- You may be able to join if you are 18 or older, have stage IIIB‑IV non‑small cell lung cancer that cannot be removed by surgery, and have not received prior treatment for advanced disease.
- What's involved
- You would receive IV infusions of either the new drug PF‑08634404 with chemotherapy or the standard drug pembrolizumab with chemotherapy. You will have regular health checks and scans to see how the cancer is responding.
- Time commitment
- The study lasts as long as the treatment helps you, with visits every 6 weeks for the first 48 weeks and then every 12 weeks.
- Phase 3: a large, late-stage study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years of age or older at screening.
- Have pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV)squamous or non-squamous NSCLC and not be a candidate for...
- Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy
- PD-L1 status available based on local testing results
- Measurable disease based on RECIST v1.1 per investigator.
You likely can't join if
- Participants with known actionable genomic alteration (AGAs), including estimated glomerular filtration rate (EGFR), anaplastic lymphoma kinase...
- Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and/or radiotherapy) may be eligible.
- Participants with clinically significant risk of hemorrhage or fistula are excluded.
- Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease...
- Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.
- Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or...
See the full eligibility criteria
- 18 years of age or older at screening.
- Have pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV)squamous or non-squamous NSCLC and not be a candidate for complete surgical resection and curative concurrent/sequential...
- Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy
- PD-L1 status available based on local testing results
- Measurable disease based on RECIST v1.1 per investigator.
- Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1
- Expected survival ≥12 weeks
- Participants with known actionable genomic alteration (AGAs), including estimated glomerular filtration rate (EGFR), anaplastic lymphoma kinase (ALK), Repressor of Silencing 1 (ROS1), neurotrophic tyrosine receptor...
- Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and/or radiotherapy) may be eligible.
- Participants with clinically significant risk of hemorrhage or fistula are excluded.
- Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
- Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.
- Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.
- History of allogeneic organ / hematopoietic stem cell transplantation.
- Evidence of noninfectious or drug-induced interstitial lung disease (ILD) or pneumonitis
- Grade ≥3 pulmonary disease unrelated to underlying malignancy
- History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial/severe venous...
- Major surgery \< 4 weeks or minor surgery \< 3 days prior to first dose of study intervention.
- History of severe bleeding tendency or coagulation dysfunction
- History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months...
- Participants with acute, chronic or symptomatic infections including participants positive for active HIV, hepatitis B virus (HBV), or Hepatitis C virus (HCV).
- Participants with history of immunodeficiency
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make...
- Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC.
- Previous treatment with immunotherapy
- Prior radiotherapy \> 30 Gy to the lung \< 6 months of first dose of study intervention
- Palliative local therapy \< 2 weeks before the first dose of study intervention;
- Non-specific immunomodulatory therapy \< 2 weeks before the first dose.
- Prior systemic anti-angiogenic therapy
- Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, adverse events from prior immunotherapy not improved to Grade 1 before screening, or required treatment with systemic immunosuppressive therapy.
- therapeutic oral or parenteral anticoagulants or thrombolytic agents \< 10 days to the first dose.
- chronic antiplatelet therapy \<7 days to randomization.
- live or attenuated live vaccine \< 4 weeks to the first dose.
- current high-dose systemic corticosteroids.
- prohibited concomitant medication(s) \< 21 days to the first dose.
- Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.
The study team makes the final eligibility decision.
Where it is enrolling
- Bullhead City, Arizona, United States
- Chandler, Arizona, United States
- Gilbert, Arizona, United States
- Glendale, Arizona, United States
- Goodyear, Arizona, United States
- Mesa, Arizona, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Fayetteville, Arkansas, United States
- Rogers, Arkansas, United States
- Springdale, Arkansas, United States
- Anaheim, California, United States
- Fountain Valley, California, United States
- Glendale, California, United States
- Laguna Hills, California, United States
- Lodi, California, United States
- Long Beach, California, United States
- Los Alamitos, California, United States
- Los Angeles, California, United States
- Manteca, California, United States
+ 358 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bullhead City, Arizona, United States; Chandler, Arizona, United States; Gilbert, Arizona, United States; Glendale, Arizona, United States; Goodyear, Arizona, United States; Mesa, Arizona, United States and 372 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.