New combo therapy aims to stop lung cancer return after surgery
NCT ID NCT04564157
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase III trial tests whether adding immunotherapy to standard chemotherapy after lung cancer surgery can delay or prevent the cancer from coming back. It enrolls 210 patients with stage IB-IIIA non-small cell lung cancer that was completely removed. Participants are randomly assigned to receive either chemotherapy alone or chemotherapy followed by maintenance immunotherapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Carboplatin and Paclitaxel (chemotherapy) plus immunotherapy
- What this could lead to
- If successful, this could show that adding immunotherapy after surgery and chemotherapy helps keep lung cancer from coming back longer than chemotherapy alone.
- What could go wrong
- This is a Phase III trial, but results are not yet available. Adding immunotherapy may increase side effects without guaranteeing better outcomes.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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210 people
The number who actually took part.
- Started
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Jan 2021
- Expected to finish
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Apr 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 diagnosed of primary non-small cell lung cancer, histologically confirmed * 2\. Patients should be classified postoperatively in stage IB (=4 cm), II or IIIA according to pathological criteria and according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology. * 3\. Complete surgical resection of the primary NSCLC is also essential. Surgeons are strongly advised to dissect or obtain samples of all accessible lymph node levels, as established in the European Society of Thoracic Surgeons guide . Consequently, at the end of the surgical intervention it is recommended to have obtained samples of a minimum of 3 (three) specific mediastinal ganglionic lobe stations (N2), one of which should include station 7, and at least one N1 station (including those resected with the tumor piece). * 4\. The surgical intervention may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy, as determined by the responsible surgeon based on intraoperative findings. Patients who have had only segmentectomies or wedge resections are not considered eligible for participation in this study. * 5\. Preoperative (neoadjuvant) use of platinum-based chemotherapy or other types of chemotherapy are not accepted. * 6\. Preoperative, postoperative, or scheduled radiation therapy is not accepted for a later time. Patients with only N2 disease, who have to receive post-operative adjuvant radiotherapy will not be eligible. * 7\. A minimum of 3 weeks must have elapsed between the surgical intervention performed for the NSCLC and the randomization. Adjuvant treatment must start between the 3rd and the 10th week from surgery. * 8\. ECOG 0-1 * 9\. Patients aged ≥ 18 years * 10\. Correct hematological, hepatic and renal function i. Neutrophils ≥ 1500×109/L ii. Platelets ≥ 100 ×109/L iii. Hemoglobin \> 9.0 g/dL iv. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault).v. AST/ALT ≤ 3 x ULN vi. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 x ULN) vii. The patients need to have a forced expiratory volume (FEV1) ≥ 1.2 liters or \>40% predicted value viii. INR/APTT within normal limits. * 11\. Patient consent must be obtained in the appropriate manner as established in the applicable local and regulatory requirements * 12\. Patients must be accessible for treatment and follow-up * 13\. 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 3 days before randomization. * 14\. All sexually active men and women of childbearing potential must use a highly 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 5 months for females and 7 months for males following the last administration of trial drugs. Exclusion Criteria: * 1\. Patients with a history of other malignant diseases, with the exception of the following: * or properly treated non-melanotic skin cancer * or cancer in situ treated with curative intent * or other malignancies treated with curative intent and without signs of disease for a period of\> 3 years after the end of the treatment and which, in the opinion of the doctor in charge of their treatment, do not present a substantial risk of relapse of the previous malignant disease. * 2\. Patients with ALK, STKB11 o KEAP1 known mutations before inclusion in this trial. * 3\. Patients with adenocarcinoma NSCLC must be tested for the common EGFR mutations before inclusion. Patients with any known EGFR mutation cannot be enrolled in the study. * 4\. Patients with a combination of microcytic and non-small cell lung cancer, a carcinoid lung tumor or large cell neuroendocrine carcinoma. * 5\. Patients that received live attenuated vaccines within 30 days prior to randomization. * 6\. History of a primary immunodeficiency, history of organ allogeneic transplantation, use of immunosuppressive drugs within 28 days before randomization or previous history of toxicity of severe immune mechanism (grade 3 or 4) with other immunological treatments * 7\. Patients with active or uncontrolled infections or with serious medical conditions or disorders that may not allow patient management as established in the protocol * 8\. Patients who have suffered untreated and / or uncontrolled cardiovascular disorders and / or who have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction in the previous year or ventricular cardiac arrhythmias that require medication, history of atrioventricular conduction of second or third degree). Patients with relevant cardiac history, even when well controlled, should have an LVEF\> 50% in the 12 weeks prior to randomization * 9\. Pregnant or breastfeeding women * 10\. Patients in whom R0 resection cannot be confirmed * 11\. Patients with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll * 12\. Patients with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease * 13\. Any positive test result for hepatitis B virus or hepatitis C virus, indicating presence of virus, e.g. Hepatitis B surface antigen (HBsAg, Australia antigen) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative) * 14\. History of allergy or hypersensitivity to any of the study drug components * 15\. Prior anti-PD1/L1 treatment
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Complejo Hospitalario de Navarra
Pamplona, Pamplona, 31008, Spain
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Complexo Hospitalario Universitario De Vigo
Vigo, Vigo, 36204, Spain
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Hospital Clínico San Carlos
Madrid, Madrid, 28040, Spain
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Hospital Clínico de Valencia
Valencia, Valencia, 46010, Spain
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Hospital Fundación de Alcorcón
Madrid, Madrid, 28922, Spain
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Hospital General Universitario de Alicante
Alicante, Alicante, 03010, Spain
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Hospital General Universitario de Valencia
Valencia, Valencia, 46014, Spain
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Hospital Parc Taulí
Barcelona, Barcelona, 08208, Spain
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Hospital Puerta de Hierro
Madrid, Madrid, 28222, Spain
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Hospital San Pedro De Alcántara
Cáceres, Cáceres, 10003, Spain
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Hospital Son Espases
Palma de Mallorca, Palma de Mallorca, 07120, Spain
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Hospital Universitari Quiron Dexeus
Barcelona, Barcelona, 08028, Spain
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Hospital Universitari Vall d' Hebron
Barcelona, Barcelona, 08035, Spain
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Hospital Universitario Cruces
Barakaldo, Vizcaya, 48903, Spain
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Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040, Spain
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Hospital Universitario Insular de Gran canaria
Las Palmas de Gran Canaria, Gran Canaria, 35016, Spain
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Hospital Universitario La Fe
Valencia, Valencia, 46026, Spain
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Hospital Universitario Lucus Augusti
Lugo, Lugo, 27003, Spain
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Hospital Universitario Nuestra Señora La Candelaria
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38009, Spain
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Hospital Universitario Virgen de la Arrixaca
El Palmar, El Palmar, 30120, Spain
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Hospital Universitario de Jaén
Jaén, Jaén, 23007, Spain
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Hospital Universitario la Paz
Madrid, Madrid, 28046, Spain
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Hospital Virgen del Rocío
Seville, Sevilla, 41013, Spain
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Hospital de Basurto
Bilbao, Bilbao, 48013, Spain
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Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041, Spain
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Hospitalario Universitario A Coruña
A Coruña, La Coruña, 15006, Spain
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ICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
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ICO Girona, Hospital Josep Trueta
Girona, Girona, 17007, Spain
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ICO Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
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Instituto Valenciano De Oncología
Valencia, Valencia, 46009, Spain
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