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New treatment option for Carcinoma
Official title Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC
ClinicalTrials.gov ID: NCT07489066
What this study is testing
What is PF-08634404?
PF-08634404 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for carcinoma.
Also referred to as SSGJ-707.
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 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.
- Phase 2: a mid-size study of how well it works
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 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
- Adequate organ function
- Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1
You likely can't join if
- Participants with known EGFR and ALK AGAs; documented negative results for EGFR and ALK AGAs are required for participants with non-squamous...
- Participants with CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.
- 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 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
- Adequate organ function
- Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1
- Part A only: Participants must have newly diagnosed, previously untreated, pathologically confirmed early-stage or LA (Stage II or IIIA/B), squamous or non-squamous NSCLC (according to the 9th edition of the Union for...
- Part B only: Participants must have pathologically confirmed early-stage or LA (Stage II or IIIA/B), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and...
- Part C only: Participants must have pathologically confirmed LA, unresectable (Stage III) squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint...
- Participants with known EGFR and ALK AGAs; documented negative results for EGFR and ALK AGAs are required for participants with non-squamous histology.
- Participants with CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.
- 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.
- Participants with any of the following respiratory conditions:
- 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...
- 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's taking place
- Hinsdale, Illinois, United States
- New Lenox, Illinois, United States
- Manati, Puerto Rico
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 - 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?
Study sites include Hinsdale, Illinois, United States; New Lenox, Illinois, United States; Manati, Puerto Rico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.