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Blood test may tailor lung cancer immunotherapy, sparing unnecessary treatment

NCT ID NCT07759492

Disease control Sponsor: Intergroupe Francophone de Cancerologie Thoracique Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial is testing whether a blood test that detects cancer DNA can guide the use of durvalumab, an immunotherapy, after standard chemoradiotherapy in patients with stage III lung cancer that cannot be removed by surgery. The goal is to see if giving durvalumab only to patients with detectable cancer DNA improves outcomes and avoids overtreating others. Participants will be divided based on the blood test result, with some receiving durvalumab and others not, to compare progression-free survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Durvalumab, an immunotherapy drug, given after chemoradiotherapy, with treatment duration guided by a blood test for cancer DNA (ctDNA).
What this could lead to
If successful, this approach could personalize immunotherapy, giving it only to those who need it, reducing side effects and healthcare costs.
What could go wrong
The trial is in Phase 2, so results are preliminary. The ctDNA test may not accurately predict who benefits, and durvalumab can cause immune-related side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 177 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Feb 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal patient care. Patients must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing. 2. Age ≥18 years. 3. ECOG Performance Status of 0 or 1. 4. Histologically proven unresectable locally advanced stage III NSCLC. 5. Diagnostic tumor tissue sample available for molecular biology analysis. 6. Measurable tumor according to RECIST1.1. 7. Patient eligible for concomitant curative CRT with authorization of two course of induction chemotherapy before the start of CRT. The minimum dose of radiotherapy is 60 Gy over 95% of tumor volumes. 8. FEV1≥40% of theoretical and PaO2≥60mmHg. 9. Hematological criteria: PNN ≥ 1.5x109/L and platelets ≥ 100x109/L, Hemoglobin ≥ 9 g/dL. 10. Creatinine clearance (according to the institution's standard method) ≥ 45 mL/min. 11. For women of childbearing potential (including women who have had a tubal ligation), serum pregnancy test must be performed and documented as negative within 14 days prior to C1D1. 12. Women of childbearing potential must remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for at least 7 months after the last dose of study drugs. Women must refrain from donating eggs during this same period. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries or uterus). Examples of contraceptive methods with a failure rate of \<1% per year include bilateral tubal ligation, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Hormonal contraceptive methods must be supplemented by a barrier method plus spermicide. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. 13. Men with female partners of childbearing potential or pregnant female partners, must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose of study treatment to avoid exposing the embryo. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. 14. Patient has national health insurance coverage. Exclusion Criteria: 1. Known EGFR activating tumor mutation (deletion LREA in exon 19, L858R or L861X mutations in exon 21, G719A/S mutation in exon 18, exon 20 insertion) or HER2 exon 20 insertion (either tissue or plasma cfDNA mutation). 2. Known ALK, ROS1, gene rearrangement as assessed by immunohistochemistry, FISH or NGS (ADN or ARN) sequencing by local genetics and/or pathology laboratory. 3. Sequential CRT, defined as the start of thoracic irradiation after the administration of the third course of chemotherapy. 4. Pleural involvement or extra-thoracic tumor lesions. 5. Comorbidity contraindicating CRT. 6. Significant lesions of interstitial lung disease on chest CT or proven interstitial lung disease. 7. History of cancer in the last 3 years, or active cancer (with the exception of basal cell carcinoma of the skin and carcinoma in situ of the uterine cervix). 8. Previous thoracic radiotherapy. 9. Previous chemotherapy in the last 3 years. 10. Pregnant or breast-feeding woman. 11. Patient under legal protection. 12. Patient unable to follow the constraints of the trial. 13. Systemic corticosteroid therapy \> 10mg/day of prednisone or equivalent and immunosuppressive treatment (with the exception of supplementary hydrocortisone treatment). 14. History of autoimmune disease, with the exception of: * Stable substituted hypothyroidism * Balanced type 1 diabetes * Vitiligo, psoriasis, lichen, without extra-dermatological involvement 15. History of anti-cancer treatment with immune checkpoint inhibitor. Randomisation Criteria: 1. Patient without immediate progression after CRT. 2. Patient with a comprehensive CAPP-Seq profile established on tumor tissue and/or ctDNA before CRT. 3. PS 0-1 4. Patient without contra-indication to immunotherapy. 5. Completion of CRT at a total dose of at least 60 Gy over 95% of tumour volumes and with at least two cycles of concurrent chemotherapy.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer stage III unresectable

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    32 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Angers - CHU

    Paris, 75009, France

  • Avignon - Institut du Cancer Avignon-Provence

    Paris, 75009, France

  • Bordeaux - CHU

    Paris, 75009, France

  • Bordeaux - Polyclinique

    Paris, 75009, France

  • Boulogne - APHP Ambroise Paré

    Paris, 75009, France

  • Brest - CHU

    Paris, 75009, France

  • Caen - CHU

    Paris, 75009, France

  • Chambéry - CH

    Paris, 75009, France

  • Clermont-Ferrand - CHU

    Paris, 75009, France

  • Colmar - CH

    Paris, 75009, France

  • Grenoble - CHU

    Paris, 75009, France

  • La Roche-Sur-Yon - CHD Vendée

    Paris, 75009, France

  • Le Mans - CHG

    Paris, 75009, France

  • Lille - Centre Oscar Lambret

    Paris, 75009, France

  • Limoges - CHU

    Paris, 75009, France

  • Lyon - HCL

    Paris, 75009, France

  • Marseille - APHM Nord

    Paris, 75009, France

  • Marseille - Institut Paoli-Calmettes

    Paris, 75009, France

  • Montpellier - CHU

    Paris, 75009, France

  • Morlaix - CH

    Paris, 75009, France

  • Nantes - Institut de Cancérologie de l'Ouest

    Paris, 75009, France

  • Paris - APHP Bichat

    Paris, 75009, France

  • Paris - APHP Cochin

    Paris, 75009, France

  • Paris - APHP Pitié-Salpêtrière

    Paris, 75009, France

  • Paris - APHP Tenon

    Paris, 75009, France

  • Paris - Saint Joseph

    Paris, 75009, France

  • Poitiers - CHU

    Paris, 75009, France

  • Reims - Institut Godinot

    Paris, 75009, France

  • Toulon - Sainte Anne HIA

    Paris, 75009, France

  • Tours - CHU

    Paris, 75009, France

  • Vannes - Bretagne Atlantique

    Paris, 75009, France

  • Villefranche sur Saône - CH

    Paris, 75009, France