AzTrials
AzTrials

Non-small Cell Lung Cancer Stage IIIPhase 2BRIDGENCT04765709

Durvalumab and Chemotherapy Induction Followed by Durvalumab and Radiotherapy in Large Volume Stage III NSCLC

A Phase 2 study testing durvalumab plus platinum-based chemotherapy (cisplatin or carboplatin plus vinorelbine or pemetrexed), Durvalumab plus radiotherapy and durvalumab in people with Non-small Cell Lung Cancer Stage III, run by Mario Negri Institute for Pharmacological Research at 3 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Standard treatment for stage III Non-Small Cells Lung Cancer (NSCLC) not eligibile for surgery is concomitant chemoradiotherapy. However median progression free survival and overall survival is still poor with only 15% of patients alive at 5 years. 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
What is being tested?
durvalumab plus platinum-based chemotherapy (cisplatin or carboplatin plus vinorelbine or pemetrexed), Durvalumab plus radiotherapy and durvalumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
3 sitesin 3 countries
Study dates
24 Sep 2021to 30 Jan 2025
Phase
Phase 2
Are there results?
None posted in the registry

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

  • FOR PART 1 (INDUCTION CHEMOTHERAPY IN ASSOCIATION WITH DURVALUMAB):
  • Capable of giving signed informed consentwhich includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (eg, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
  • Age > 18 years at time of study entry
  • Histologically- or cytologically-documented NSCLC, in locally advanced (Stage III-v.8 IASLC)
  • Eligible for platinum-based chemotherapy (platinum - pemetrexed for non-squamous and platinum-vinorelbine for squamous histology)
  • Patients not eligible for surgery and chemoradiation for Dosimetry not meeting the following constraints to organs at risk (Kong 2011, Marks 2010, De Ruysscher 2017, Marks 2010, Gagliardi 2010, Wang 2017, Antonia 2017, Kirkpatrick 2010):
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  • Total mean lung dose (Right Lung+Left Lung-GTV) < 20 Gy and/or
  • Lung V20 defined as percentage of normal parenchyma receiving 20 Gy or more (Right Lung+Left Lung-PTV) < 35%
  • Heart V45 <30% and/or Mean Heart Dose <20 Gy
  • If the dosimetry criteria are met, other clinical conditions for avoiding concurrent chemoradiation are:
  • Bilateral supraclavicular involvement
  • Contralateral mediastinal and/or hilar involvement
  • Primary tumor > 7 cm or several nodules in different lobes of the same lung or bulky mediastinal lymphonodes.
  • Each patient will be discussed in a web multidisciplinary team among all the three involved Cancer Core Europe [CCE] centers. If dosimetry criteria are met, patient not eligible for surgery and chemoradiation due to other clinical condition(s) will be specifically defined and confirmed by at least 2 out of 3 CCE
  • Tumor sample requirements: availability of an archived tumour tissue block (or unstained slides to perform local PDL1 assessment following protocol procedure)
  • Patient's willingness to undergo blood draws to provide plasma and blood samples for analysis according to study objectives
  • Patients without history of previous radiotherapy. Patients with previous radiotherapy performed to the thorax, including radiotherapy for breast cancer, especially in the last 10 years, have to be discussed case by case in the Multidisciplinary Team Meeting
  • Life expectancy ≥12 weeks at the start of treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  • Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle- stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
  • Patient willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • Adequate normal organ and marrow function as defined below:
  • Haemoglobin ≥9.0 g/dL (5.59 mmol/L)
  • Absolute neutrophil count (ANC) > 1.5 x 109/L (> 1500/mm3)
  • Platelet count ≥100 x 109/L (100000/mm3)
  • Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
  • AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal
  • Adequate renal function defined as normal serum creatinine levels or calculated creatinine clearance (according to Cockroft-Gault or by 24 hour-urine collection): ≥60 ml/min for patient receiving cisplatin ≥45 ml/min for patient receiving carboplatin.
  • Body weight > 30 Kg
  • Absence of a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy agents and/or to durvalumab and/or to any of their excipients.
  • FOR PART 2 (RADIOTHERAPY CONCURRENTLY WITH DURVALUMAB):
  • Absence of progressive disease by RECIST 1.1 together with evidence of tumor shrinkage at the evaluation conducted at the end of part 1. Whether the degree of tumor shrinkage will be sufficient to consider the patient eligible for part 2 will be discussed in a web multidisciplinary team among involved CCE centers.
  • ECOG Performance Status of 0 - 1
  • Absence of dyspnea of minimal exertion or oxygen requirement after CT+D
  • Sufficient PFTs performed after the last cycle of CT+D:
  • FEV1 > 1L or ≥ 30%
  • DLCO > 30%
  • The patient's dosimetry must meet the following constraints to organs at risk (Kong 2011, Marks 2010, De Ruysscher 2017, Marks 2010, Gagliardi 2010, Wang 2017, Antonia 2017, Kirkpatrick 2010):
  • Spinal cord maximum dose < 50 Gy
  • Total mean lung dose (Right Lung+Left Lung-GTV) < 20 Gyand/or
  • Lung V20 defined as percentage of normal parenchyma receiving 20 Gy or more (Right Lung+Left Lung-PTV) < 35%
  • Heart V45 <30% and/or Mean Heart Dose <20 Gy
  • In case of dosimetry criteria met before part 1, confirmed resolution of clinical condition(s) that led to initial inegibility. The resolution of the clinical condition is discussed in the multidisciplinary team, at least 2 out of 3 CCE must agree.
  • FOR PART 3 (MAINTENANCE WITH DURVALUMAB):
  • Evidence of partial response or stable disease at the evaluation conducted at the end of Part 2
  • Absence of grade 2-3 pneumonitis

Who cannot join

  • Stage IV NSCLC
  • Patient amenable to curative intent surgery or concurrent chemoradiation
  • Mixed small cell and non-small cell lung cancer histology
  • Patients who already received therapy for locally advanced NSCLC
  • Dyspnea of minimal exertion or oxygen requirement
  • Recent medical history of cardiac events during the last 6 months (ischemic or congestive heart failure)
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  • Pancoast tumors
  • Prior exposure to any anti-PD-1 or anti-PD-L1 antibody, including durvalumab
  • Participation in another clinical study with an investigational product during the last 4 weeks, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
  • Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
  • Active or prior documented autoimmune disease within the past 2 years or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
  • Patients with vitiligo or alopecia
  • Patients with Grave's disease not requiring systemic treatment within the past 2 years
  • Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
  • Any chronic skin condition that does not require systemic therapy (e.g. patients with psoriasis not requiring systemic treatment within the past 2 years)
  • Patients without active disease in the last 2 years may be included but only after consultation with the study physician
  • Patients with celiac disease controlled by diet alone
  • Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses, ongoing or active infection, including any patient known to have evidence of acute or chronic hepatitis B (positive HBV surface antigen (HBsAg) result), hepatitis C, human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies) or tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent. [Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.]
  • History of another primary malignancy except for
  • Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of study drug and of low potential risk for recurrence
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated carcinoma in situ without evidence of disease, e.g. cervical cancer in situ
  • Superficial bladder cancer without evidence of disease
  • Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy
  • Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
  • Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
  • Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
  • Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of investigational product.
  • History of allogenic organ transplantation.
  • Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms
  • History of active primary immunodeficiency
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
  • Systemic corticosteroids at physiologic doses not to exceed 10 mg daily of prednisone or its equivalent
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) Systemic steroid administration required as prophylaxis against or to manage toxicities arising from chemotherapy and/or radiotherapy delivered as part of therapy for locally advanced NSCLC is allowed
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
  • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  • Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

France1 site

  • Gustave Roussy Institute

    Paris

Other trials in France

Italy1 site

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

Other trials in Italy

Spain1 site

  • Vall d'Hebron Barcelona Hospital

    Barcelona

Other trials in Spain

About this study

Official title: BRIDGE Trial: Phase II Trial of durvalumaB and chemotheRapy Induction Followed by Durvalumab and Radiotherapy in larGe volumE Stage III NSCLC

Standard treatment for stage III Non-Small Cells Lung Cancer (NSCLC) not eligibile for surgery is concomitant chemoradiotherapy. However median progression free survival and overall survival is still poor with only 15% of patients alive at 5 years. The addition of maintenance therapy with durvalumab after chemoradiation showed a significant benefit in PFS and OS, with good tolerability and no concerns in terms of safety. However, about 30% of patients with stage III are not eligible to concurrent chemoradiotherapy because of large volumes of the tumor. To date, these patients are initially treated with chemotherapy with the aim of reducing tumor volumes and allowing sequential radiotherapy. Response rate ranges between 25-30% and majority of patients will not become suitable for radiotherapy.

The combination of immunotherapy plus standard chemotherapy in advanced stages doubles response rates and provides major tumor shrinkage compared to standard chemotherapy alone. For these reasons, the investigators want to exploit the synergistic effect of immunotherapy combined with chemotherapy in the induction phase, in order to render suitable for radiotherapy a larger number of patients, and in a second phase the synergistic effect with radiotherapy.

Read more

Based on these premises the investigators designed a single arm, phase 2 trial to determine the efficacy and safety of combining immunotherapy with the drug durvalumab in association with standard chemotherapy and subsequently with standard radiotherapy, followed by a treatment of maintenance with only durvalumab.

The study population includes patients with NSCLC not eligible for surgery or concurrent chemoradiation at diagnosis because of large tumor volumes.

BRIDGE trial aims to evaluate the proportion of patients who did not progress and who achieved a mean lung dose <20 Gy and/or a lung V20<35% (response) after part 1. The primary objective of the study is to increase the proportion of patients eligible for immunotherapy plus radiotherapy after induction with durvalumab and chemotherapy, in comparison with historical controls.

This study will last approximately 60 months and will include approximately 65 eligible patients in 3 international cancer centres of excellence.

Read the detailed description

Standard treatment for stage III Non-Small Cells Lung Cancer (NSCLC) not eligibile for surgery is concomitant chemoradiotherapy. However median progression free survival and overall survival is still poor with only 15% of patients alive at 5 years. The addition of maintenance therapy with durvalumab after chemoradiation showed a significant benefit in PFS and OS, with good tolerability and no concerns in terms of safety. However, about 30% of patients with stage III are not eligible to concurrent chemoradiotherapy because of large volumes of the tumor. To date, these patients are initially treated with chemotherapy with the aim of reducing tumor volumes and allowing sequential radiotherapy. Response rate ranges between 25-30% and majority of patients will not become suitable for radiotherapy.

The combination of immunotherapy plus standard chemotherapy in advanced stages doubles response rates and provides major tumor shrinkage compared to standard chemotherapy alone. For these reasons, the investigators want to exploit the synergistic effect of immunotherapy combined with chemotherapy in the induction phase, in order to render suitable for radiotherapy a larger number of patients, and in a second phase the synergistic effect with radiotherapy.

Based on these premises the investigators designed a single arm, phase 2 trial to determine the efficacy and safety of combining immunotherapy with the drug durvalumab in association with standard chemotherapy and subsequently with standard radiotherapy, followed by a treatment of maintenance with only durvalumab.

The study population includes patients with NSCLC not eligible for surgery or concurrent chemoradiation at diagnosis because of large tumor volumes.

The study consists of 3 parts:

  • Part 1: induction with durvalumab plus chemotherapy.
  • Part 2: patients with a sufficient tumor shrinkage to be considered eligible for part 2 and they will be treated concomitantly with durvalumab and radiotherapy.
  • Part 3: patients with partial response or stable disease after part 2 will be eligible for durvalumab maintenance, for up to 2 years or until disease progression or unacceptable toxicity.

BRIDGE trial aims to evaluate the proportion of patients who did not progress and who achieved a mean lung dose <20 Gy and/or a lung V20<35% (response) after part 1. The primary objective of the study is to increase the proportion of patients eligible for immunotherapy plus radiotherapy after induction with durvalumab and chemotherapy, in comparison with historical controls.

This study will last approximately 60 months and will include approximately 65 eligible patients in 3 international cancer centres of excellence.

Being tested
durvalumab plus platinum-based chemotherapy (cisplatin or carboplatin plus vinorelbine or pemetrexed), Durvalumab plus radiotherapy, durvalumab
Keywords
Carcinoma, Non-Small-Cell Lung, Radiotherapy, Immunotherapy, durvalumab, Stage III, Unresectable NSCLC, Phase II, Concomitant immuno-radiotherapy, Concomitant immuno-chemotherapy, Chemotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • durvalumab plus platinum-based chemotherapy (cisplatin or carboplatin plus vinorelbine or pemetrexed)Combination product

    Induction therapy: durvalumab plus histology-based chemotherapy regimen (cisplatin or carboplatin plus vinorelbine for squamous histology and pemetrexed for non-squamous histology).

  • Durvalumab plus radiotherapyCombination product

    Concomitant durvalumab and radiotherapy

  • durvalumabBiological

    Consolidation treatment with durvalumab

Study groups in NCT04765709
Study groupRoleWhat they receive
BRIDGE single armExperimentalTreatment plan: * Part 1: induction with durvalumab plus histology-based chemotherapy regimen. * Part 2: patients with a sufficient tumor shrinkage to be considered eligible for part 2 and they will be treated concomitantly with durvalumab and radiotherapy. * Part 3: patients with partial response or stable disease after part 2 will be eligible for durvalumab maintenance, for up to 2 years or until disease progression or unacceptable toxicity.
Receives: Combination Product: durvalumab plus platinum-based chemotherapy (cisplatin or carboplatin plus vinorelbine or pemetrexed); Combination Product: Durvalumab plus radiotherapy; Biological: durvalumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients who did not progressed and who achieved a mean lung dose <20 Gy and/or a lung V20<35% (response) after part 1

    The primary objective of the study is to increase the proportion of patients eligible for immunotherapy plus radiotherapy after induction with durvalumab and chemotherapy, in comparison to historical controls.

    Measured: At the end of part 1 of induction chemo-immunotherapy/before part 2 (assessed up to 60 months)

Secondary outcomes (4)

  1. Progression-Free Survival (PFS) of patients receiving durvalumab and chemotherapy induction followed by immuno-radiotherapy and durvalumab consolidation.

    PFS is defined as the time from the date of start of induction treatment until the date of objective disease progression or death to any cause whichever comes first. PFS will be evaluated using RECIST 1.1 criteria according to investigators and blinded central review (BCR).

    Measured: From the date of start of induction chemo-immunotherapy until the date of first documented progression or death from any cause, whichever came first (assessed up to 60 months)

  2. Proportion of patients with complete response or partial response (as best response)

    To evaluate Objective Response Rate (ORR) of each phase of treatment and the overall response rate. ORR is defined as the proportion of patients with complete or partial response (as best response) according to RECIST 1.1 as assessed by Investigators and BCR.

    Measured: Assessed up to 60 months

  3. Overall Survival (OS) of patients receiving durvalumab and chemotherapy induction followed by immuno-radiotherapy and durvalumab consolidation.

    OS is defined as the time from the date of start of induction treatment until death due to any cause. Patients alive at the time of statistical analysis will be censored at their last information on vital status.

    Measured: Assessed up to 60 months

  4. Frequency and nature of adverse reactions (ARs) and Serious Adverse Events (SAEs) (toxicity and safety).

    The assessment of safety will be mainly based on adverse reactions (ARs) and the frequency and nature of SAEs. Toxicity and safety will be evaluated during each part of the program, throughout study duration.

    Measured: Assessed up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start24 Sep 2021
  3. Primary completion30 Jan 2025
  4. Study completion30 Jan 2025

Why it stopped: Low enrolment rate

Resources

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
Not applicable
Intervention model
Single group
Model description
multicentric, open label, single arm, minimax Simon 2 stages, phase 2 trial
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04765709
Sponsor's protocol ID
IRFMN-NSCLC-8187
Other IDs
2019-004025-24, 2019
Acronym
BRIDGE
Status last verified
Mar 2025
First submitted
8 Feb 2021
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alexandrov LB, Nik-Zainal S, Wedge DC, Aparicio SA, Behjati S, Biankin AV, Bignell GR, Bolli N, Borg A, Borresen-Dale AL, Boyault S, Burkhardt B, Butler AP, Caldas C, Davies HR, Desmedt C, Eils R, Eyfjord JE, Foekens JA, Greaves M, Hosoda F, Hutter B, Ilicic T, Imbeaud S, Imielinski M, Jager N, Jones DT, Jones D, Knappskog S, Kool M, Lakhani SR, Lopez-Otin C, Martin S, Munshi NC, Nakamura H, Northcott PA, Pajic M, Papaemmanuil E, Paradiso A, Pearson JV, Puente XS, Raine K, Ramakrishna M, Richardson AL, Richter J, Rosenstiel P, Schlesner M, Schumacher TN, Span PN, Teague JW, Totoki Y, Tutt AN, Valdes-Mas R, van Buuren MM, van 't Veer L, Vincent-Salomon A, Waddell N, Yates LR; Australian Pancreatic Cancer Genome Initiative; ICGC Breast Cancer Consortium; ICGC MMML-Seq Consortium; ICGC PedBrain; Zucman-Rossi J, Futreal PA, McDermott U, Lichter P, Meyerson M, Grimmond SM, Siebert R, Campo E, Shibata T, Pfister SM, Campbell PJ, Stratton MR. Signatures of mutational processes in human cancer. Nature. 2013 Aug 22;500(7463):415-21. doi: 10.1038/nature12477. Epub 2013 Aug 14.

    PubMed 23945592

  • Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.

    PubMed 28885881

  • Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Ozguroglu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25.

    PubMed 30280658

  • Auperin A, Le Pechoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29.

    PubMed 20351327

  • Bayman N, Blackhall F, McCloskey P, Taylor P, Faivre-Finn C. How can we optimise concurrent chemoradiotherapy for inoperable stage III non-small cell lung cancer? Lung Cancer. 2014 Feb;83(2):117-25. doi: 10.1016/j.lungcan.2013.11.017. Epub 2013 Dec 1.

    PubMed 24373738

  • Bracci L, Schiavoni G, Sistigu A, Belardelli F. Immune-based mechanisms of cytotoxic chemotherapy: implications for the design of novel and rationale-based combined treatments against cancer. Cell Death Differ. 2014 Jan;21(1):15-25. doi: 10.1038/cdd.2013.67. Epub 2013 Jun 21.

    PubMed 23787994

  • Bradley JD, Paulus R, Komaki R, Masters G, Blumenschein G, Schild S, Bogart J, Hu C, Forster K, Magliocco A, Kavadi V, Garces YI, Narayan S, Iyengar P, Robinson C, Wynn RB, Koprowski C, Meng J, Beitler J, Gaur R, Curran W Jr, Choy H. Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): a randomised, two-by-two factorial phase 3 study. Lancet Oncol. 2015 Feb;16(2):187-99. doi: 10.1016/S1470-2045(14)71207-0. Epub 2015 Jan 16.

    PubMed 25601342

  • Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P, Drake CG, Camacho LH, Kauh J, Odunsi K, Pitot HC, Hamid O, Bhatia S, Martins R, Eaton K, Chen S, Salay TM, Alaparthy S, Grosso JF, Korman AJ, Parker SM, Agrawal S, Goldberg SM, Pardoll DM, Gupta A, Wigginton JM. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012 Jun 28;366(26):2455-65. doi: 10.1056/NEJMoa1200694. Epub 2012 Jun 2.

    PubMed 22658128

  • Brahmer JR, Horn L, Gandhi L, Spigel DR, Antonia SJ, Rizvi NA, et al. Nivolumab (anti-PD-1, BMS-936558, ONO-4538) in patients (pts) with advanced non-small-cell lung cancer (NSCLC): Survival and clinical activity by subgroup analysis [ASCO abstract 8112]. J Clin Oncol 2014;32(Suppl)

  • Brookmeyer R, Crowley J. A confidence interval for the median survival time. Biometrics 1982, 38, 29-41. doi:10.2307/2530286

  • Butte MJ, Keir ME, Phamduy TB, Sharpe AH, Freeman GJ. Programmed death-1 ligand 1 interacts specifically with the B7-1 costimulatory molecule to inhibit T cell responses. Immunity. 2007 Jul;27(1):111-22. doi: 10.1016/j.immuni.2007.05.016. Epub 2007 Jul 12.

    PubMed 17629517

  • De Ruysscher D, Reynders K, Van Limbergen E, Lambrecht M. Radiotherapy in combination with immune checkpoint inhibitors. Curr Opin Oncol. 2017 Mar;29(2):105-111. doi: 10.1097/CCO.0000000000000352.

    PubMed 28085679

  • De Ruysscher D, Faivre-Finn C, Moeller D, Nestle U, Hurkmans CW, Le Pechoux C, Belderbos J, Guckenberger M, Senan S; Lung Group and the Radiation Oncology Group of the European Organization for Research and Treatment of Cancer (EORTC). European Organization for Research and Treatment of Cancer (EORTC) recommendations for planning and delivery of high-dose, high precision radiotherapy for lung cancer. Radiother Oncol. 2017 Jul;124(1):1-10. doi: 10.1016/j.radonc.2017.06.003. Epub 2017 Jun 27.

    PubMed 28666551

  • Drake CG, McDermott DF, Sznol M, Choueiri TK, Kluger HM, Powderly JD et al. Survival, safety, and response duration results of nivolumab (Anti-PD-1; BMS-936558; ONO-4538) in a phase I trial in patients with previously treated metastatic renal cell carcinoma (mRCC): Long-term patient follow-up [abstract 4514]. J Clin Oncol 2013;31(Suppl)

  • Dunn GP, Old LJ, Schreiber RD. The three Es of cancer immunoediting. Annu Rev Immunol. 2004;22:329-60. doi: 10.1146/annurev.immunol.22.012703.104803.

    PubMed 15032581

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing durvalumab plus platinum-based chemotherapy (cisplatin or carboplatin plus vinorelbine or pemetrexed), Durvalumab plus radiotherapy and durvalumab in people with Non-small Cell Lung Cancer Stage III, run by Mario Negri Institute for Pharmacological Research at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 48 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Low enrolment rate). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who did not progressed and who achieved a mean lung dose <20 Gy and/or a lung V20<35% (response) after part 1 (time frame: At the end of part 1 of induction chemo-immunotherapy/before part 2 (assessed up to 60 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04765709, which also lists 65 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.

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