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Blood Test to Guide Immunotherapy for Lung Cancer

N/A

Recruiting

Led By Meghan Mooradian, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if using a blood test for circulating tumor DNA can help doctors decide when to stop therapy in patients with melanoma or lung cancer. They want to know if patients with these cancers

Who is the study for?

This trial is for adults over 18 with metastatic melanoma or NSCLC who've been on immunotherapy for at least a year and show disease control. They must have had no serious side effects from the therapy, have tumor tissue available for testing, and be expected to live more than 3 months.

What is being tested?

The study evaluates if measuring ctDNA after one year of immunotherapy can help decide when to stop treatment in patients with melanoma or non-small-cell lung cancer, comparing their disease-free survival against past data.

What are the potential side effects?

Since this trial involves monitoring ctDNA levels rather than testing new drugs, there are no direct side effects from the intervention being studied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate the 12month disease-free survival (DFS) in ctDNA negative patients

Secondary study objectives

Overall survival of the ctDNA negative cohort

Side effects data

From 2023 Phase 1 & 2 trial • 40 Patients • NCT04020185

71%

Injection site pain

43%

Nausea

43%

Fatigue

29%

Constipation

29%

Pain

14%

Acute respiratory failure

14%

Cancer pain

14%

Oral candidiasis

14%

Disease progression

14%

Injection site erythema

14%

Chills

14%

Injection site irritation

14%

Diarrhoea

14%

Peripheral swelling

14%

Vomiting

14%

Abdominal pain upper

14%

Dyspnoea

14%

Cough

14%

Decreased appetite

14%

Hyponatraemia

14%

Hypokalaemia

14%

Headache

14%

Myalgia

14%

Weight decreased

14%

Haematuria

14%

Abdominal pain

14%

Paraesthesia

14%

Tremor

14%

Arthralgia

14%

Dry mouth

100%

80%

60%

40%

20%

Study treatment Arm

Monotherapy 1200

Monotherapy 800

Monotherapy 200 μg

Combination Therapy 800 μg

Monotherapy 100 μg

Monotherapy 400 μg

Combination Therapy 1200 μg

Combination Therapy 24000 μg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Active SurveillanceExperimental Treatment1 Intervention

Patients with 12 month history of immune checkpoint inhibitors (ICI) with stable or partial or complete responses and negative ctDNA at pre-screening, will stop ICI therapy and begin active surveillance with blood draws and standard of care imaging for 12 months.

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