ClinicalTrials.gg
Not yet recruitingNCT07759492IDEATIONUpdated Aug 12, 2026

Personnalized Immunotherapy in Patients With Stage III Non-small Cell Lung Cancer

A Phase 2 interventional study of CAPP-Seq technique and Durvalumab in Non-small Cell Lung Cancer Stage III Unresectable, sponsored by Intergroupe Francophone de Cancerologie Thoracique. Not yet recruiting at 32 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Intergroupe Francophone de Cancerologie Thoracique · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
177
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 94 studies testing durvalumab in Carcinoma, Non-Small-Cell Lung — 16 open to participants now, 37 under way, 11 of them phase 3. durvalumab · Carcinoma, Non-Small-Cell Lung.

Planned enrollment
26th of 94
177 · median 74
Started
2026
with 2 others
Phase 2
58 of 94
11 open now
Primary completion
2030-11
later than 35 of 36 live
Registered
94th of 94
by date
Lead sponsor
3 of 94
Intergroupe Francophone de Cancerologie Thoracique

Among the 94 studies testing durvalumab in Carcinoma, Non-Small-Cell Lung, this one is the 26th largest by planned enrollment, is one of 3 that started in 2026, is one of 58 in phase 2, reaches primary completion later than 35 of the 36 other live ones, and was the 94th registered.

Carcinoma, Non-Small-Cell Lung

7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Open to participants now

16 of the 94 studies testing durvalumab in Carcinoma, Non-Small-Cell Lung are open now, in 12 countries. Recruiting first, the newest first:

10 more — sign in →

By country, each count listing its studies:

All 16 open studies →

About durvalumab

durvalumab: first FDA approval 2017 (IMFINZI), first EMA approval 2018. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 94 studies testing durvalumab in Carcinoma, Non-Small-Cell Lung, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Non-small Cell Lung Cancer Stage III Unresectable

Keywords

  • NSCLC
  • stage III
  • locally advanced
  • unresectable
  • consolidation immunotherapy
  • ctDNA-guided
  • chemoradiotherapy
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients must have signed and dated an IRB/IEC approved written 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. Performance Status of 0 or 1.
  4. 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. ≥40% of theoretical and PaO2≥60mmHg.
  9. Hematological criteria: PNN ≥ 1.5x109/L and ≥ 100x109/L, ≥ 9 g/dL.
  10. (according to the institution's standard method) ≥ 45 mL/min.
  11. For women of (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 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 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

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 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 therapy > 10mg/day of prednisone or equivalent and treatment (with the exception of supplementary hydrocortisone treatment).
  14. History of 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 .

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 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.
Terms in these criteria, in plain language(16)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
177 participants (estimated)

Study arms

  • Other
    Arm A : durvalumab

    This arm is a non-comparative control group

    Drug: Durvalumab

  • Experimental
    Arm B : durvalumab or no treatment

    Patients in Arm B who are MRD positive will receive durvalumab. Patients in Arm B who are MRD negative will not receive durvalumab.

    Diagnostic Test: CAPP-Seq technique · Drug: Durvalumab

Interventions

  • Diagnostic testCAPP-Seq technique

    Patients in Arm B will be divided into 2 groups : MRD positive and MRD negative depending on the result of the CAPP-Sequ technique.

  • 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.

    Also known as: Durvalumab Arm A, Durvalumab Arm B

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months after randomisation.

Secondary outcomes

  1. 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.

    Time frame: Around 54 months

  2. Overall Survival (OS)

    OS is defined as the time from date of randomization to the date of death due to any cause.

    Time frame: Around 54 months.

  3. 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).

    Time frame: 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).

  4. 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.

    Time frame: Around 54 months

  5. General health status

    General health status will be measured using the EQ-5D-5L questionnaire.

    Time frame: Around 54 months

07

Study locations

32 sites
  • Angers - CHU
    Paris, 75009, France
    • Contact Dr Marie Capucine WILLEMIN · Contactcontact@ifct.fr · +33 (0)156811046
  • Avignon - Institut du Cancer Avignon-Provence
    Paris, 75009, France
    • Contact Dr Naila BACHA DUFOUR · Contactcontact@ifct.fr · +33 (0)156811046
  • Bordeaux - CHU
    Paris, 75009, France
  • Bordeaux - Polyclinique
    Paris, 75009, France
    • Contact Dr Sigolène GALLAND-GIRODET · Contactcontact@ifct.fr · +33 (0)156811046
  • Boulogne - APHP Ambroise Paré
    Paris, 75009, France
    • Contact Pr Etienne GIROUX LEPRIEUR · Contactcontact@ifct.fr · +33 (0)156811046
  • Brest - CHU
    Paris, 75009, France
    • Contact Dr François LUCIA · Contactcontact@ifct.fr · +33 (0)156811046
  • Caen - CHU
    Paris, 75009, France
    • Contact Dr Jeannick MADELAINE · Contactcontact@ifct.fr · +33 (0)156811046
  • Chambéry - CH
    Paris, 75009, France
    • Contact Dr Anne BARANZELLI · Contactcontact@ifct.fr · +33 (0)156811046
  • Clermont-Ferrand - CHU
    Paris, 75009, France
  • Colmar - CH
    Paris, 75009, France
  • Grenoble - CHU
    Paris, 75009, France
    • Contact Pr Anne-Claire TOFFART · Contactcontact@ifct.fr · +33 (0)156811046
  • La Roche-Sur-Yon - CHD Vendée
    Paris, 75009, France
    • Contact Dr Perrine CREQUIT · Contactcontact@ifct.fr · +33 (0)156811046
  • Le Mans - CHG
    Paris, 75009, France
    • Contact Dr Camille GUGUEN · Contactcontact@ifct.fr · +33 (0)156811046
  • Lille - Centre Oscar Lambret
    Paris, 75009, France
    • Contact Dr Elisabeth GAYE · Contactcontact@ifct.fr · +33 (0)156811046
  • Limoges - CHU
    Paris, 75009, France
  • Lyon - HCL
    Paris, 75009, France
    • Contact Dr Thomas PIERRET · Contactcontact@ifct.fr · +33 (0)156811046
  • Marseille - APHM Nord
    Paris, 75009, France
    • Contact Pr Laurent GREILLIER · Contactcontact@ifct.fr · +33 (0)156811046
  • Marseille - Institut Paoli-Calmettes
    Paris, 75009, France
    • Contact Dr Anne MADROSZYK · Contactcontact@ifct.fr · +33 (0)156811046
  • Montpellier - CHU
    Paris, 75009, France
  • Morlaix - CH
    Paris, 75009, France
  • Nantes - Institut de Cancérologie de l'Ouest
    Paris, 75009, France
    • Contact Dr Judith RAIMBOURG · Contactcontact@ifct.fr · +33 (0)156811046
  • Paris - APHP Bichat
    Paris, 75009, France
    • Contact Dr Camille MEHLMAN · Contactcontact@ifct.fr · +33 (0)156811046
  • Paris - APHP Cochin
    Paris, 75009, France
  • Paris - APHP Pitié-Salpêtrière
    Paris, 75009, France
    • Contact Dr Baptiste ABBAR · Contactcontact@ifct.fr · +33 (0)156811046
  • Paris - APHP Tenon
    Paris, 75009, France
    • Contact Dr Eleonor RIVIN DEL CAMPO · Contactcontact@ifct.fr · +33 (0)156811046
  • Paris - Saint Joseph
    Paris, 75009, France
    • Contact Dr Charles NALTET · Contactcontact@ifct.fr · +33 (0)156811046
  • Poitiers - CHU
    Paris, 75009, France
    • Contact Dr Clotilde DELDYCKE · Contactcontact@ifct.fr · +33 (0)156811046
  • Reims - Institut Godinot
    Paris, 75009, France
    • Contact Dr Amélie LEMOINE · Contactcontact@ifct.fr · +33 (0)156811046
  • Toulon - Sainte Anne HIA
    Paris, 75009, France
    • Contact Dr Antoine-Raphaël BRONSTEIN · Contactcontact@ifct.fr · +33 (0)156811046
  • Tours - CHU
    Paris, 75009, France
    • Contact Dr Pauline TOSSAN · Contactcontact@ifct.fr · +33 (0)156811046
  • Vannes - Bretagne Atlantique
    Paris, 75009, France
    • Contact Dr Angélique LECLERC · Contactcontact@ifct.fr · +33 (0)156811046
  • Villefranche sur Saône - CH
    Paris, 75009, France
08

References and documents

Related links

Individual participant data

Plan to share: 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2030, 48 months later.

Of 730 non-industry phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 84. This study's planned 48 months is below that.

Counting every sponsor, half of 1,047 studies reached it within 48 months; a quarter within 30 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 7, 2026
First posted
Aug 12, 2026
StartEst.
Nov 2026
Primary completionEst.
Nov 2030
CompletionEst.
Feb 2031
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07759492
Lead sponsor
Intergroupe Francophone de Cancerologie Thoracique
Responsible party
Sponsor
First posted
Aug 12, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2030 (estimated)
Completion
Feb 2031 (estimated)
Last update
Aug 12, 2026

Study contacts

Contact IFCT
Contact
contact@ifct.fr
+33 156811046
Etienne GIROUX-LEPRIEUR, MD, PhD
study chair · Cancer Institute APHP. Université Paris-Saclay, APHP - Hôpital Ambroise Paré
Benoit Roch, MD
study chair · Arnaud de Villeneuve Hospital - University Hospital of Montpellier

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Durvalumab

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