Genomic-Guided RT for Lung Cancer

Recruiting in Palo Alto (17 mi)

Overseen byThomas Dilling, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) with concurrent chemotherapy in the management of stage II and III non-small cell lung cancer (NSCLC).

Eligibility Criteria

Adults diagnosed with stage II or III non-small cell lung cancer (NSCLC) who are in good physical condition (ECOG 0-1), have a life expectancy over 12 weeks, and can provide a fresh tumor biopsy. Prior treatments are allowed. Participants must not be pregnant, breastfeeding, or have had certain other cancers within the last two years. They should not be on immunosuppressive medications recently and must agree to use effective contraception.

Inclusion Criteria

I have recovered from recent surgery and my surgeon has cleared me.

My lung cancer is at Stage 2 or 3 and cannot be removed by surgery.

My lung cancer type has been confirmed with a recent biopsy.

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Exclusion Criteria

I have recovered from any major surgery or significant injury at least 14 days before starting the study drug.

I have cancer that has spread to my brain or the lining around my brain.

I haven't taken strong immune-weakening medicines in the last 14 days, except for minor exceptions like nasal sprays or low-dose steroids.

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Treatment Details

Interventions

Genomically Guided Radiation Therapy (RT) (Radiation Therapy)

Trial OverviewThe trial is testing personalized radiation therapy guided by genomic information alongside standard chemotherapy for patients with locally advanced NSCLC. The goal is to see if this tailored approach is feasible and beneficial compared to traditional methods.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Arm C: unable to calculate RSIExperimental Treatment1 Intervention

Participants in will receive standard RT dose of 60Gy in 30 fractions targeting the primary tumor and any involved regional lymph nodes.

Group II: Arm B: RSI predicts dose > 60 GyExperimental Treatment1 Intervention

Participants will receive treatment with RxRSI guided boost to the primary tumor up to 81Gy (2.7Gy/fraction).

Group III: Arm A: RSI predicts dose ≤ 60 GyExperimental Treatment1 Intervention

Participants will receive standard RT dose of 60Gy in 30 fractions targeting the primary tumor and any involved regional lymph nodes.