Non-small Cell Lung Cancer Stage III UnresectablePhase 2IDEATIONNCT07759492
Personnalized Immunotherapy in Patients With Stage III Non-small Cell Lung Cancer
A Phase 2 study testing CAPP-Seq technique and Durvalumab in people with Non-small Cell Lung Cancer Stage III Unresectable, run by Intergroupe Francophone de Cancerologie Thoracique at 32 sites in France.
Trial summary
The reference treatment for locally advanced (stage III) non-small cell lung cancer (NSCLC) is concomitant chemoradiotherapy (CRT) followed by durvalumab consolidation for 1 year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Stage III Unresectable
- What is being tested?
- CAPP-Seq technique and Durvalumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 32 sitesFrance
- Study dates
- Nov 2026to Feb 2031
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Age ≥18 years.
- ECOG Performance Status of 0 or 1.
- Histologically proven unresectable locally advanced stage III NSCLC.
- Diagnostic tumor tissue sample available for molecular biology analysis.
- Measurable tumor according to RECIST1.1.
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- 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.
- FEV1≥40% of theoretical and PaO2≥60mmHg.
- Hematological criteria: PNN ≥ 1.5x109/L and platelets ≥ 100x109/L, Hemoglobin ≥ 9 g/dL.
- Creatinine clearance (according to the institution's standard method) ≥ 45 mL/min.
- 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.
- 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.
- 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.
- Patient has national health insurance coverage.
Who cannot join
- 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).
- Known ALK, ROS1, gene rearrangement as assessed by immunohistochemistry, FISH or NGS (ADN or ARN) sequencing by local genetics and/or pathology laboratory.
- Sequential CRT, defined as the start of thoracic irradiation after the administration of the third course of chemotherapy.
- Pleural involvement or extra-thoracic tumor lesions.
- Comorbidity contraindicating CRT.
- Significant lesions of interstitial lung disease on chest CT or proven interstitial lung disease.
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- 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).
- Previous thoracic radiotherapy.
- Previous chemotherapy in the last 3 years.
- Pregnant or breast-feeding woman.
- Patient under legal protection.
- Patient unable to follow the constraints of the trial.
- Systemic corticosteroid therapy > 10mg/day of prednisone or equivalent and immunosuppressive treatment (with the exception of supplementary hydrocortisone treatment).
- History of autoimmune disease, with the exception of:
- Stable substituted hypothyroidism
- Balanced type 1 diabetes
- Vitiligo, psoriasis, lichen, without extra-dermatological involvement
- History of anti-cancer treatment with immune checkpoint inhibitor.
- Randomisation Criteria:
- Patient without immediate progression after CRT.
- Patient with a comprehensive CAPP-Seq profile established on tumor tissue and/or ctDNA before CRT.
- PS 0-1
- Patient without contra-indication to immunotherapy.
- 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.
Trial locations and contacts
32 sites in 1 country. Contact the study team or a site near you to ask about taking part.
32 sites in 1 country
France32 sites
Angers - CHU
Paris, 75009
Contact Dr Marie Capucine WILLEMIN, +33 (0)156811046, contact@ifct.fr
Avignon - Institut du Cancer Avignon-Provence
Paris, 75009
Contact Dr Naila BACHA DUFOUR, +33 (0)156811046, contact@ifct.fr
Bordeaux - CHU
Paris, 75009
Contact Pr Maéva ZYSMAN, +33 (0)156811046, contact@ifct.fr
Bordeaux - Polyclinique
Paris, 75009
Contact Dr Sigolène GALLAND-GIRODET, +33 (0)156811046, contact@ifct.fr
Boulogne - APHP Ambroise Paré
Paris, 75009
Contact Pr Etienne GIROUX LEPRIEUR, +33 (0)156811046, contact@ifct.fr
Brest - CHU
Paris, 75009
Contact Dr François LUCIA, +33 (0)156811046, contact@ifct.fr
Caen - CHU
Paris, 75009
Contact Dr Jeannick MADELAINE, +33 (0)156811046, contact@ifct.fr
Chambéry - CH
Paris, 75009
Contact Dr Anne BARANZELLI, +33 (0)156811046, contact@ifct.fr
Clermont-Ferrand - CHU
Paris, 75009
Contact Dr Patrick MERLE, +33 (0)156811046, contact@ifct.fr
Colmar - CH
Paris, 75009
Contact Dr Lionel MOREAU, +33 (0)156811046, contact@ifct.fr
Grenoble - CHU
Paris, 75009
Contact Pr Anne-Claire TOFFART, +33 (0)156811046, contact@ifct.fr
La Roche-Sur-Yon - CHD Vendée
Paris, 75009
Contact Dr Perrine CREQUIT, +33 (0)156811046, contact@ifct.fr
Le Mans - CHG
Paris, 75009
Contact Dr Camille GUGUEN, +33 (0)156811046, contact@ifct.fr
Lille - Centre Oscar Lambret
Paris, 75009
Contact Dr Elisabeth GAYE, +33 (0)156811046, contact@ifct.fr
Limoges - CHU
Paris, 75009
Contact Dr Thomas EGENOD, +33 (0)156811046, contact@ifct.fr
Lyon - HCL
Paris, 75009
Contact Dr Thomas PIERRET, +33 (0)156811046, contact@ifct.fr
Marseille - APHM Nord
Paris, 75009
Contact Pr Laurent GREILLIER, +33 (0)156811046, contact@ifct.fr
Marseille - Institut Paoli-Calmettes
Paris, 75009
Contact Dr Anne MADROSZYK, +33 (0)156811046, contact@ifct.fr
Montpellier - CHU
Paris, 75009
Contact Dr Benoit ROCH, +33 (0)156811046, contact@ifct.fr
Morlaix - CH
Paris, 75009
Contact Dr Hugues MOREL, +33 (0)156811046, contact@ifct.fr
Nantes - Institut de Cancérologie de l'Ouest
Paris, 75009
Contact Dr Judith RAIMBOURG, +33 (0)156811046, contact@ifct.fr
Paris - APHP Bichat
Paris, 75009
Contact Dr Camille MEHLMAN, +33 (0)156811046, contact@ifct.fr
Paris - APHP Cochin
Paris, 75009
Contact Pr Marie WISLEZ, +33 (0)156811046, contact@ifct.fr
Paris - APHP Pitié-Salpêtrière
Paris, 75009
Contact Dr Baptiste ABBAR, +33 (0)156811046, contact@ifct.fr
Paris - APHP Tenon
Paris, 75009
Contact Dr Eleonor RIVIN DEL CAMPO, +33 (0)156811046, contact@ifct.fr
Paris - Saint Joseph
Paris, 75009
Contact Dr Charles NALTET, +33 (0)156811046, contact@ifct.fr
Poitiers - CHU
Paris, 75009
Contact Dr Clotilde DELDYCKE, +33 (0)156811046, contact@ifct.fr
Reims - Institut Godinot
Paris, 75009
Contact Dr Amélie LEMOINE, +33 (0)156811046, contact@ifct.fr
Toulon - Sainte Anne HIA
Paris, 75009
Contact Dr Antoine-Raphaël BRONSTEIN, +33 (0)156811046, contact@ifct.fr
Tours - CHU
Paris, 75009
Contact Dr Pauline TOSSAN, +33 (0)156811046, contact@ifct.fr
Vannes - Bretagne Atlantique
Paris, 75009
Contact Dr Angélique LECLERC, +33 (0)156811046, contact@ifct.fr
Villefranche sur Saône - CH
Paris, 75009
Contact Dr Luc ODIER, +33 (0)156811046, contact@ifct.fr
About this study
Official title: ctDNA-guIDEd consolidATION Immunotherapy After Chemoradiotherapy in Patients With Stage III Non-small Cell Lung Cancer
The reference treatment for locally advanced (stage III) non-small cell lung cancer (NSCLC) is concomitant chemoradiotherapy (CRT) followed by durvalumab consolidation for 1 year. This strategy is based on the results of the PACIFIC trial, which compared, in a randomized fashion after CRT, the superiority of treatment with durvalumab at a dose of 1500 mg every 4 weeks for 12 months to placebo in patients with non-progressive disease. The coprimary endpoints of this trial were progression-free survival (PFS) and overall survival (OS). This study was positive and showed a benefit in PFS and OS. However, less than half of patients (49%) received the full 12 months of durvalumab in this study, one-third of these discontinuations being related to toxicity. Furthermore, the prescription of durvalumab in this setting is not currently guided by any companion biomarker. As a result, the systematic prescription of a 12-month consolidation immunotherapy after CRT, without any selection criteria, leads to a possible overtreatment of patients whose survival would have been prolonged without additional treatment. These patients are systematically exposed to a potentially high and serious risk of toxicity in the course of immunotherapy. It is therefore crucial to move towards a more individualized approach in the prescription of consolidation immunotherapy after CRT in stage III NSCLC. This would ensure that the most appropriate treatment is delivered to patients who are likely to derive significant clinical benefit, while concurrently minimizing the exposure of other patients to potentially severe clinical toxicities. Additionally, such an approach would help protect healthcare systems from unnecessary economic burden, preventing the allocation of resources to treatments that offer limited therapeutic value.
- Being tested
- CAPP-Seq technique, Durvalumab
- Keywords
- NSCLC, stage III, locally advanced, unresectable, consolidation immunotherapy, ctDNA-guided, chemoradiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPP-Seq techniqueDiagnostic test
Patients in Arm B will be divided into 2 groups : MRD positive and MRD negative depending on the result of the CAPP-Sequ technique.
DurvalumabDrug
Also called Durvalumab Arm A, Durvalumab Arm B
Patients in Arm A (non-comparative control) will receive durvalumab treatment. The patients in Arm B who are MRD positive (see CAPP-Seq technique intervention) will receive durvalumab treatment.
| Study group | Role | What they receive |
|---|---|---|
| Arm A : durvalumab | Other | This arm is a non-comparative control group Receives: Drug: Durvalumab |
| Arm B : durvalumab or no treatment | Experimental | Patients in Arm B who are MRD positive will receive durvalumab. Patients in Arm B who are MRD negative will not receive durvalumab. Receives: Diagnostic Test: CAPP-Seq technique; Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of a personalized strategy of consolidation immunotherapy based on the assessment of MRD post-CRT in stage III NSCLC.
12-month PFS rate from randomization as assessed by an independent review committee (IRC). The primary endpoint is 12-month progression free survival (PFS). The analysis will be conducted in the FAS population. PFS is defined as the time between the date of randomization and the first date of documented progression, as determined by an IRC, or death due to any cause, whichever occurs first.
Measured: 12 months after randomisation.
Secondary outcomes (5)
PFS as assessed by the investigator
PFS is defined as the time between the date of randomization and the first date of documented progression, as determined by investigator, or death due to any cause, whichever occurs first.
Measured: Around 54 months
Overall Survival (OS)
OS is defined as the time from date of randomization to the date of death due to any cause.
Measured: Around 54 months.
Tolerance and safety
Incidence, nature, and severity of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 6.0 (NCI CTCAE v6.0).
Measured: From time of informed consent through end of therapeutic period (consolidation treatment or no consolidation treatment) and up to 90 days after (maximum of 1 year and 3 months).
Time until definitive HRQoL deterioration (TUDD)
For the symptom scale "Global health status/QOL" of questionnaire QLQ-C30, TUDD is defined as the time from inclusion until the date of first clinically meaningful symptom deterioration (an increase in the score from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful symptom deterioration, regardless of whether the subject withdraws from therapy or receives another anticancer therapy prior to symptom deterioration.
Measured: Around 54 months
General health status
General health status will be measured using the EQ-5D-5L questionnaire.
Measured: Around 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2030 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer Stage III UnresectableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne GIROUX-LEPRIEUR, MD, PhD, Study chair, Cancer Institute APHP. Université Paris-Saclay, APHP - Hôpital Ambroise ParéBenoit Roch, MD, Study chair, Arnaud de Villeneuve Hospital - University Hospital of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759492
- Sponsor's protocol ID
- IFCT-2501
- Other IDs
- 2025-522801-39-00, 2025
- Acronym
- IDEATION
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data underlying the results reported in this article, as well as the study protocol and statistical analysis plan, will be made available after deidentification immediately following publication and for three years. Researchers who provide a methodologically sound proposal for any purpose may direct proposals to contact@ifct.fr . To gain access, data requestors will need to sign a data access agreement that requires approval by the French Cooperative Thoracic Intergroup.