Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can immunotherapy extend remission in Limited-Stage lung cancer?

NCT ID NCT02046733

Disease control Sponsor: ETOP IBCSG Partners Foundation 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This trial is investigating whether adding two immunotherapy drugs, nivolumab and ipilimumab, after standard chemotherapy and radiation can help people with limited-stage small cell lung cancer. Even though initial treatment often works well, the cancer frequently returns within a couple of years. The study compares standard treatment alone versus standard treatment followed by the immunotherapy combination, aiming to see if it can delay cancer progression and improve survival.

What this could mean

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

Active substance
nivolumab and ipilimumab (immunotherapy drugs)
What this could lead to
If successful, this could lead to a new treatment strategy that helps keep limited-stage small cell lung cancer from returning after standard therapy.
What could go wrong
This is a phase II trial, so results are preliminary. The drugs may cause immune-related side effects, and not all patients may benefit.

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

222 people

The number who actually took part.

Started

Dec 2015

Finished

Feb 2022

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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 for enrolment: * Histologically or cytologically confirmed small cell lung carcinoma. * Untreated limited-stage disease (with the exception of one cycle of chemotherapy given prior to enrolment) as defined by stage I-IIIB based on 7th TNM classification (IASLC classification for SCLC proposal). M0 proven by whole body FDG-PET CT including a contrast-enhanced CT of thorax and upper abdomen (incl. liver, kidney, adrenals); OR contrast-enhanced CT of thorax and upper abdomen (incl. liver, kidney, adrenals) and bone scan; AND brain MRI (or contrast enhanced CT of the brain) within 28 days before start of chemotherapy. * Age ≥ 18 years. * ECOG performance status 0-1. * Adequate haematological function: haemoglobin \> 9 g/dL, neutrophils count \>1.5×109/L, platelet count \> 100 × 109/L. * Adequate liver function: total bilirubin \< 2.5 × ULN, ALT and/or AST \< 2.5 × ULN, alkaline phosphatase \< 5 ULN. * Adequate renal function: Calculated creatinine clearance ≥ 30 mL/min (Cockroft-Gault). * Pulmonary function FEV1 of 1.0L or \> 40% predicted value and DLCO \> 40% predicted value. * Patient capable of proper therapeutic compliance, and accessible for correct follow-up. * Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before beginning of chemotherapy. * All sexually active men and women of childbearing potential must use an effective contraceptive method (two barrier methods or a barrier method plus a hormonal method) during the study treatment and for a period of at least 12 months following the last administration of trial drugs. * Measurable or evaluable disease (according to RECIST 1.1 criteria). Not eligible: patients with only one measurable or evaluable tumour lesion which was resected or irradiated prior to enrolment. * Written Informed Consent (IC) must be signed and dated by the patient and the investigator prior to any trial-related intervention for a) Chemo-radiotherapy treatment and PCI, and subsequent randomisation, including mandatory biological samples b) Optional biological material collection, long-term storage and future use of biological material for translational research. Exclusion Criteria for enrolment: * Patient with mixed small-cell and non-small-cell histologic features. * Patient with pleural or pericardial effusions proven to be malignant. * Patients who have had in the past 5 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ ductal carcinoma of the breast (if no RT was involved). * Patients with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection and any other serious underlying medical processes that could affect the patient's capacity to participate in the study. * Ongoing clinically serious infections requiring systemic antibiotic or antiviral, antimicrobial, antifungal therapy. * Known or suspected hypersensitivity to nivolumab or ipilimumab or any of their excipients. * Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results. * Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (e.g. steroids) treatment, such as but not limited to ulcerative colitis and Crohn´s disease, rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, or autoimmune vasculitis (eg, Wegener's granulomatosis). * Subjects with an autoimmune paraneoplastic syndrome requiring concurrent immunosuppressive treatment. * Interstitial lung disease or pulmonary fibrosis. * Women who are pregnant or in the period of lactation. * Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study. * Patients with any concurrent anticancer systemic therapy (except for chemotherapy cycle 1). * HIV, active Hepatitis B or Hepatitis C infection. * Previous radiotherapy to the thorax (prior to inclusion), including RT for breast cancer. * Planned radiotherapy to lung of mean dose \> 20 Gy or V20 \> 35 %. * Patients who received treatment with an investigational drug agent during the 3 weeks before enrolment in the study. * Prior chemotherapy or radiotherapy for SCLC. Exception: one cycle of chemotherapy (as specified to section 10.2 of the protocol) may be administered prior to enrolment. Inclusion Criteria for randomisation: * Chemo-radiotherapy completed per protocol: 4 cycles of chemotherapy, ≥85% of PTV of thoracic radiotherapy, as well as completed, mandatory PCI. * Non-PD after chemo-radiotherapy and PCI. * ECOG performance status 0-2. * Recovery of all adverse events to a grade ≤1, except for fatigue, appetite, oesophagitis and renal impairment (where ≤2 is allowed) and alopecia (any grade). * Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before randomisation. Exclusion criteria for randomisation: * Less than 4 cycles of chemotherapy administered, less than 85% PTV of thoracic radiotherapy delivered, or PCI not completed. * Progressive disease after chemo-radiotherapy and PCI.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Limited-stage small-cell lung cancer are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

small cell lung carcinoma type 1 diabetes mellitus 12

As listed by the trial registrant

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

Limited-stage small-cell lung cancer Small cell lung cancer

Contacts and locations

Locations

  • AP-HM

    Marseille, France

  • Austin Hospital

    Melbourne, Australia

  • Avignon - Institut Sainte-Catherine

    Avignon, France

  • Bendigo Hospital

    Bendigo, Australia

  • CH

    Mulhouse, France

  • CHI

    Toulon, France

  • CHU

    Caen, France

  • CHU

    Grenoble, France

  • CHU

    Rennes, France

  • CHU

    Toulouse, France

  • CHU

    Tours, France

  • CRLCC

    Nantes, France

  • Caen - Centre François Baclesse

    Caen, France

  • Centre Hospitalier Général

    Le Mans, 72037, France

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, Switzerland

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier, France

  • Clermont-Ferrand

    Clermont-Ferrand, France

  • Clinico San Carlos

    Madrid, Spain

  • Coffs Harbour Health Campus

    Coffs Harbour, Australia

  • Créteil - CHI

    Créteil, France

  • Epworth HealthCare - Richmond

    Richmond, Australia

  • Hospital Clínico Universitario De Valencia

    Valencia, Spain

  • Hospital De La Santa Creu I Sant Pau

    Barcelona, Spain

  • Hospital General Universitario Alicante

    Alicante, Spain

  • Hospital Puerta de Hierro

    Madrid, Spain

  • Hospital Universitario 12 Octubre

    Madrid, Spain

  • Hospital Universitario Central De Asturias

    Oviedo, Spain

  • Hospital Universitario Cruces

    Barakaldo, Spain

  • Hospital Universitario Fundacion Jimenez Díaz

    Madrid, Spain

  • Hospital Virgen De La Salud

    Toledo, Spain

  • Hôpital Louis Pradel

    Lyon, France

  • Institut Gustave Roussy

    Villejuif, France

  • Klinikum Esslingen

    Esslingen am Neckar, Germany

  • Klinikum München-Bogenhausen

    München, Germany

  • Krankenhaus der Barmherzigen Brüder

    Trier, Germany

  • LungenClinic Grosshansdorf GmbH

    Großhansdorf, 22927, Germany

  • Lyon - Sud

    Lyon, France

  • Maastro Clinic

    Maastricht, Netherlands

  • NNSWLHD - The Tweed Hospital

    Lismore, Australia

  • Nice - CRLCC

    Nice, France

  • Nouvel Hôpital Civil

    Strasbourg, France

  • Orléans - CH

    Orléans, France

  • Paris - Bichat

    Paris, France

  • Paris - Saint-Louis

    Paris, France

  • Paris - Tenon

    Paris, France

  • Percy/Armées

    Clamart, France

  • Pius-Hospital Oldenburg

    Oldenburg, Germany

  • Port Macquarie Base Hospital

    Port Macquarie, Australia

  • Princess Alexandra Hospital

    Woolloongabba, Australia

  • Riverina Cancer Centre

    Mount Kuring-Gai, Australia

  • Royal Brisbane and Women's Hospital (QLD)

    Herston, Australia

  • Royal Hobart Hospital

    Hobart, Australia

  • Royal Marsden

    London, United Kingdom

  • St James' University Hospital

    Leeds, United Kingdom

  • Suresnes

    Suresnes, France

  • The Christie NHS Foundation Trust

    Manchester, United Kingdom

  • Thoracic Oncology Centre Munich

    München, Germany

  • University Hospital Gasthuisberg, KU Leuven

    Leuven, 3000, Belgium

  • University Hospital Zürich

    Zurich, Switzerland

  • Universitätsklinikum Tübingen

    Tübingen, Germany

  • VUMC

    Amsterdam, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.