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RecruitingPhase 2

ctDNA to Predict Response to Chemo-Immunotherapy and Detect Minimal Residual Disease in Non-Small Cell Lung Cancer

A Phase 2 Study of Circulating Tumor DNA to Predict Response to Neoadjuvant Treatment and De-escalation Adjuvant Immunotherapy in Early-Stage NSCLC (DNA-PREDICT)

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

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The purpose of this study is to determine if a blood test called circulating tumor DNA (ctDNA) can be used to predict how well patients will respond to treatment and if there is any cancer left after surgery."
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 whether a blood test called ctDNA, which looks for DNA from cancer cells, can predict treatment response and find cancer left after surgery. It is for adults with certain stages of non-small cell lung cancer that can be removed by surgery. The study also tests whether pembrolizumab can help keep cancer from coming back in people with a positive ctDNA test or signs of cancer after treatment and surgery.

The purpose of this study is to determine if a blood test called circulating tumor DNA (ctDNA) can be used to predict how well patients will respond to treatment and if there is any cancer left after surgery. The investigators will also study if a drug called pembrolizumab can help prevent the cancer from coming back in patients who are ctDNA-positive or who have evidence of cancer after treatment and surgery.

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

Eligibility

Who can join

  • You must be at least 18 years old when you sign the consent form.
  • You must be fully active or able to do light work, even if you cannot do hard physical activity.
  • A tissue test must confirm non-small cell lung cancer at stage IB (tumor at least 4 cm), II, or IIIB (N2, meaning cancer in certain chest lymph nodes).
  • A team of specialists must agree that your cancer can be removed by surgery. You must plan to get chemotherapy and immunotherapy, and sometimes radiation, before surgery.
  • Your cancer must be measurable using the study’s rules.
  • You must have a tumor tissue sample for testing for a protein called PD-L1. The sample must be new or collected within 6 months before joining.
  • The tissue sample and its lab report must be sent before you are assigned to a study group. The sample must come from a core needle or surgical biopsy. Fine needle samples taken using ultrasound through the airways are not enough; core needle samples taken this way are allowed.

Who can't join

  • You cannot join if your cancer is locally advanced, cannot be removed by surgery, or has spread to distant parts of the body. If a PET/CT scan shows enlarged lymph nodes in the middle of your chest, samples from specific nodes are required to check the cancer’s stage.
  • You cannot join if your cancer has a known EGFR gene mutation or ALK gene rearrangement.
  • You cannot join if you have had cancer treatment before, including chemotherapy, radiation, or immunotherapy.
  • You cannot join if you used drugs that weaken the immune system within 3 weeks before treatment given ahead of surgery.
  • You cannot join if your ability to make decisions is impaired.

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

Official eligibility criteria

Inclusion Criteria: 1. Eligible participants must be males or females ≥18 years of age on day of signing the informed consent form. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 3. Participants with histologically confirmed Stage IB (≥4 cm), II, or IIIB (N2) NSCLC (as per the 8th American Joint Committee on Cancer (AJCC)) who are considered resectable by a multidisciplinary team and who are going to be treated with neoadjuvant treatment including chemotherapy, immunotherapy, and in some cases radiation before surgery 4. Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) 5. Participants must have tumor tissue available for programmed cell death ligand 1 (PD-L1) immunohistochemical (IHC) testing performed by a third-party analyzing lab during the screening period: 1. Either a formalin-fixed, paraffin-embedded (FFPE) tissue block or unstained tumor tissue sections, with an associated pathology report, must be submitted for biomarker evaluation prior to randomization. The tumor tissue sample may be fresh or archival if obtained within 6 months prior to enrollment 2. Tissue must be a core needle biopsy, excisional or incisional biopsy. Fine needle biopsies obtained by endobronchial ultrasound (EBUS) are not considered adequate for biomarker review and randomization. Core needle biopsies obtained by EBUS are acceptable for randomization. Exclusion Criteria: 1. Presence of locally advanced, unresectable, or metastatic disease. Mediastinal lymph node samples at levels 4 (bilaterally) and 7 are required for clinical staging to assess nodal involvement in participants with mediastinal adenopathy on positron emission tomography-computed tomography scan (PET/CT). 2. Participants with known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) translocation 3. Previous exposure to anti-cancer therapy, including chemotherapy, radiotherapy or immunotherapy, and previous exposure to immunosuppressive drugs within 3 weeks before neoadjuvant treatment 4. Participants with impaired decision-making capacity .

Study sites (1)

FL