RecruitingPhase not listed

GEMINI-NSCLC: NSCLC Biomarker Study

TEMPUS GEMINI NSCLC STUDY: A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Non-Small Cell Lung Cancer (NSCLC)

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 looks at how non-small cell lung cancer (NSCLC) changes during usual care. It uses health records, tumor samples, and repeated blood tests to learn whether cancer DNA in blood can help predict cancer's return and treatment results. It is for adults with NSCLC who will have surgery or who have stage IV cancer and plan to start immune-based treatment.

GEMINI NSCLC Study is a non-interventional study that will be collecting clinical and molecular health information from patients with NSCLC who will receive longitudinal blood collection in addition to their standard of care therapy and disease surveillance with the goals of identifying the molecular evolution of lung cancer with standard of care therapy, and determining the utility of ctDNA dynamics to predict risk of recurrence and therapeutic outcomes.

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

Eligibility

Who can join

  • Both groups: Be age 18 or older and willing and able to give informed consent, meaning you agree to join after learning about the study.
  • Both groups: Agree to extra blood draws during routine follow-up visits and provide a tumor sample that reflects your current cancer.
  • Group 1: Have known or suspected stage I–IIIB NSCLC that can be removed with surgery aimed at a cure. Suspected cancer must be confirmed as NSCLC.
  • Group 1: Have had or plan to have surgery. People with or without cancer gene changes may join.
  • Group 2: Have stage IV NSCLC confirmed by a tissue test that cannot be cured with surgery or radiation. Radiation to ease pain or other problems is allowed.
  • Group 2: Plan to start immunotherapy, which helps the immune system fight cancer, alone or with chemotherapy. Any earlier immunotherapy given before or after surgery must have ended at least 12 months ago.
  • Group 2: Tumor testing must show no listed EGFR, ALK, ROS1, BRAF, NTRK, MET, or RET gene changes with available first-choice targeted treatments. KRAS G12C or HER2 changes may qualify if the study's immunotherapy rules are met.
  • Group 1 members may move to Group 2 if cancer returns, a tissue test confirms it, and they meet all Group 2 rules.

Who can't join

  • Both groups: Do not have known or suspected NSCLC, or have another disease instead, such as sarcoidosis, lymphoma, or cancer that spread to the lung from elsewhere.
  • Both groups: Are unwilling to have extra blood draws.
  • Both groups: Have another cancer unless it was diagnosed and all its treatment ended more than 2 years before the lung cancer diagnosis. Certain low-risk basal cell or squamous cell skin cancers are exceptions.
  • Group 1: Have a tumor at the top of the lung for which chemotherapy and radiation together before surgery are recommended.
  • Group 1: Have stage III cancer that cannot be removed with surgery and are a candidate for chemotherapy and radiation followed by immunotherapy.
  • Group 1: Have stage IIIB or IIIC cancer with confirmed tumor or lymph node spread for which chemotherapy and radiation, rather than surgery, are recommended.
  • Group 1: Receive radiation as the main treatment instead of surgery.

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

Official eligibility criteria

For Cohort 1 Inclusion, the participant has/is: * A known or suspected NSCLC treated with curative intent -(surgery with or without perioperative (neoadjuvant or adjuvant) therapy). * Suspected NSCLC - Patients with a high index of suspicion for the diagnosis of NSCLC that is resectable may sign informed consent prior to undergoing diagnostic procedure at the discretion of the physician. NCCN Guidelines allow for clinical stage IA cancers to proceed directly to definitive surgery. Per NCCN Guidelines, if a preoperative tissue diagnosis has not been obtained, then an intraoperative diagnosis will be obtained. If a diagnosis of NSCLC is not confirmed and/or the tumor is not resectable, then the patient will be a screen failure. * Undergone or planning to undergo a surgical resection - (Patients with stages I-IIIB who are resectable - per NCCN guidelines of resectability) * Both patients who lack molecular abnormalities and those with identified molecular abnormalities may enroll. Choice of perioperative therapy is to follow SOC therapeutic guidelines for the participant's molecular and PD-L1 profile. * 18 years old or older * Willing and able to provide informed consent * Willing to have additional blood samples collected during routine surveillance visits * Must submit tumor sample representative of current disease For Cohort 1 Exclusion, the participant has/is: * Patients with superior sulcus tumors who are candidates for preoperative concurrent chemoradiation. * Stage III locally advanced and unresectable patients who are candidates for chemoradiation followed by immunotherapy. * It is expected that all patients on the cohort will be treated with a definitive surgical resection. Thus, clinical stage IIIB and IIIC patients who subsequently demonstrate pathologically confirmed N3 nodal disease or T4 N2 or 3 per any confirmatory procedure listed in NCCN guidelines for which definitive chemoradiotherapy rather than surgery is recommended per NCCN Guidelines are not eligible. * Patients who receive primary radiation (in lieu of surgery if they are not surgical candidates). For Cohort 2 Inclusion, the participant has/is: * Histologically documented Stage IV NSCLC (de novo metastatic or relapse setting) not amenable to curative surgery or radiation therapy. Palliative radiation (for instance for impending bony fracture or to control pain) is allowed at any time during the protocol at the physician's discretion. * Intended to receive first line immunotherapy (as monotherapy or in combination with chemotherapy). Patients who have had previous exposure to immunotherapy in the neoadjuvant or adjuvant setting are allowed to enroll as long as 12 months have elapsed since the prior exposure. * Patients in surveillance on Cohort 1 are eligible to roll over to Cohort 2 at the time of recurrence as long as they have had histologic confirmation of recurrence and have been off immunotherapy for 12 months or greater and meet all other inclusion/exclusion criteria. * Tumors that lack activating EGFR mutations (e.g., exon 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation) and ALK fusions. Also, per NCCN Guideline recommended testing, tumors must also lack ROS1, BRAF, NTRK 1/2/3, METex14 skipping mutations, and RET for which there is available front-line targeted therapy. Only those patients with KRAS G12C mutations and ERBB2 (HER2) mutations with no contraindications to immunotherapy (PD-L1 1) for which there are no approved front-line targeted therapies and for whom immunotherapy would be the preferred front-line therapy are eligible. * Patients may be enrolled with local molecular testing and those results will be provided. * Patients may be enrolled with local molecular testing and those results will be provided. * 18 years and older * Willing and able to provide informed consent * Willing to have additional blood samples collected during routine surveillance visits * Must submit tumor sample representative of current disease Exclusion Criteria (both Cohorts): * Patients without a known or suspected NSCLC diagnosis, or other disease processes such as sarcoidosis, lymphoma, or metastatic cancer from other sites. * Not willing to have additional blood samples collected * Patients with a secondary malignancy must have been both diagnosed \> 2 years from the lung cancer of interest and have completed all therapy for that malignancy (including extended adjuvant therapy) \> 2 years prior to diagnosis of the lung cancer of interest with the exception of the following: * Patients with superficial basal cell carcinoma of low-risk histology per NCCN Guidelines (Low-risk histologic subtypes include nodular, superficial, and other non-aggressive growth patterns such as keratotic, infundibulocystic, and fibroepithelioma of Pinkus) and low-risk for recurrence per NCCN Guidelines (location on trunk or extremities, size \< 2 cm, primary (not recurrent), with well-defined borders) can be included even if they are diagnosed \< 2 years from the lung cancer of interest. * Patients with superficial squamous cell carcinoma of low-risk pathology per NCCN Guidelines (verrucous, keratoacanthomatous) and low-risk for recurrence per NCCN Guidelines (located on trunk or extremities; 2 cm in size; primary lesion (vs. recurrent); well to moderately differentiated; \< 2 mm thick and no invasion beyond subcutaneous fat; negative for perineural invasion; and negative for lymphatic or vascular involvement) can be included even if they are diagnosed \< 2 years from the lung cancer of interest.

Study sites (58)

AL

AR

CA

CT

FL

GA

HI

IA

IL

IN

MD

MO

NC

NE

NJ

NV

NY

OH

OK

OR

PA

SC

TN

VA

WA

WI