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RecruitingPhase 2

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

AN INTERVENTIONAL, OPEN-LABEL, PHASE 2 STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY OR IN COMBINATION IN ADULT PARTICIPANTS WITH EARLY-STAGE RESECTABLE OR LOCALLY ADVANCED UNRESECTABLE NON-SMALL CELL LUNG CANCER

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well a new medicine, PF-08634404, works alone or with chemotherapy. It is for adults with early-stage or locally advanced non-small cell lung cancer (NSCLC), which may or may not be removable with surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have a tumor tissue sample available for testing.
  • Have local test results for PD-L1, a protein tested in cancer tissue.
  • Have organs that work well enough based on medical tests.
  • Be fully active or able to do light work despite some limits on heavy activity.
  • Part A: Have newly diagnosed, untreated Stage II or IIIA/B NSCLC confirmed by tissue testing. Be able to receive treatment to shrink the tumor, then surgery to remove it completely.
  • Part B: Have Stage II or IIIA/B NSCLC and have had chemotherapy plus immune-based treatment before surgery. Have had complete tumor removal, but still have living cancer cells found in the removed tissue. Be able to receive more treatment after surgery.
  • Part C: Have Stage III NSCLC that cannot be removed by surgery. Have received at least 60 Gy of radiation and at least 2 cycles of platinum-based chemotherapy at the same time, with no cancer growth or worsening.

Who can't join

  • Have certain EGFR or ALK gene changes. People with the non-squamous type of NSCLC must have negative test results for these changes.
  • Have lesions in the brain or spinal cord, including cancer in their coverings, or pressure on the spinal cord.
  • Have a serious bleeding risk, blood-clotting problems, or a fistula—an abnormal opening between body parts. Certain serious gut problems within the past 6 months also rule out joining.
  • Have had another cancer within 3 years, remaining cancer from an earlier diagnosis, or more than mild side effects still present from past cancer treatment.
  • Have had a severe allergy to a study treatment ingredient or certain antibody medicines, or an organ or blood-forming stem cell transplant from a donor.
  • Have certain lung inflammation or severe lung disease not caused by cancer; certain uncontrolled health problems within 6 months; active, long-term, or symptom-causing infections; or a history of a weakened immune system.
  • Have had major surgery less than 4 weeks or minor surgery less than 3 days before treatment. Other medical or mental health conditions, suicide-related thoughts or behavior, or abnormal lab tests may also make joining unsafe.
  • Be breastfeeding, or be unwilling to follow required birth control measures if they apply to you.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) with disease that is considered resectable, as assessed by a multidisciplinary evaluation, which must include a thoracic surgeon who performs lung cancer surgery as a prominent part of his/her practice. The participant must be a candidate for neoadjuvant therapy followed by complete surgical resection. * 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 American Joint Committee on Cancer lung cancer TNM staging system) and have undergone complete surgical resection. The participant must be considered a candidate for adjuvant therapy and must not have achieved pCR with SOC neoadjuvant chemo-immunotherapy. * 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 Committee on Cancer lung cancer TNM staging system) and have received ≥ 60 Gy of radiation and ≥ 2 cycles of definitive, platinum-based concurrent chemotherapy and achieved SD or better per RECIST 1.1. Exclusion Criteria: * 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 thromboembolic events. * 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 prior to the first dose. * 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 the participant inappropriate for the study. * Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.

Study sites (15)

AL

CA

GA

IL

NE

NM

TN