New drug cocktail aims to stop lung cancer relapse in High-Risk patients

NCT ID NCT06431633

Disease control Sponsor: Fundación GECP Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether two immunotherapy drugs, sacituzumab and zimberelimab, can keep lung cancer from returning after surgery. It includes 129 patients whose cancer did not fully disappear with pre-surgery treatment. Participants are split into three groups: observation only, zimberelimab alone, or both drugs together, and are followed for about 2 years to see who stays cancer-free.

What this could mean

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

Active substance: Sacituzumab Govitecan and Zimberelimab (immunotherapy drugs)
What this could lead to: If successful, this combination could help prevent lung cancer from coming back after surgery, offering a new option for patients with residual disease.
What could go wrong: This is a mid-stage trial with only 129 participants, so results may not apply to everyone. The drugs can cause side effects like fatigue, nausea, or immune reactions.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 129 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Nov 2031

An estimate. End dates often move.

Lead sponsor

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

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: * 1\. Patients diagnosed of primary non-small cell lung cancer, histologically confirmed. * 2\. Patients should be classified postoperatively in stage IB, IIA, IIB, IIIA or IIIB (N2) according to pathological criteria (pTNM) and according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology * 3\. Complete surgical resection (R0) 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 specific mediastinal ganglionic lobe stations (N2), one of which should include station 7, and at least one N1 station * 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 except if R0 resection can be confirmed. * 5\. Only patients that do not achieve pathological complete response (pCR) seen in the surgical piece after neoadjuvant therapy are eligible. * 6\. Preoperative (neoadjuvant) use of platinum-based chemotherapy + immunotherapy (anti PD-1) is mandatory. * 7\. 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. * 8\. 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. * 9\. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * 10\. Patients aged ≥ 18 years. * 11\. PDL1 value analysed locally (hospital must be able to provide this value before randomization) * 12\. PET-CT and brain CT before randomization to confirm the absence of distant disease. * 13\. Adequate hematologic and organ function * 14.All patients are notified of the investigational nature of this study and signed a written in-formed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention. * 15.For female patients of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception * 16\. For male patients with female partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception * 17\. Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drugs. * 18.Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug. * 19.Patient capable of proper therapeutic compliance and accessible for correct follow-up * 20\. Patients with a life expectancy of at least more than 12 weeks Exclusion Criteria: * 1\. Patients with a history of other malignant diseases, with the exception of the following: * properly treated non-melanotic skin cancer * 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.T4 patients with invasion of heart, great vessels, carina, trachea, oesophagus or spine * 3\. Patients with ALK translocation, STK11 o KEAP1 known mutations before inclusion in this trial. * 4\. 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. * 5\. Patients with a combination of microcytic and non-small cell lung cancer, a carcinoid lung tumor or large cell neuroendocrine carcinoma * 6\. Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of randomization. * 7\. Patients that received live attenuated vaccines within 30 days prior to randomization * 8\. 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 * 9\. Patients with active or uncontrolled infections or with serious medical conditions or disorders that may not allow patient management as established in the protocol. * 10\. Patients who have suffered untreated and / or uncontrolled cardiovascular disorders and / or who have symptomatic cardiac dysfunction * 11\. Pregnant or breastfeeding women * 12\. Patients in whom R0 resection cannot be confirmed. * 13\. Patients with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. * 14.Patients with a condition requiring systemic treatment with either corticosteroids 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. * 15\. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded. * 16\. History of allergy or hypersensitivity to any of the study drug components * 17\. Pleural or pericardial effusion, both will be considered indicative of metastatic disease unless proven otherwise. Patients with pleural effusion not visible on chest-X-ray or too small to perform diagnostic puncture safely may be included. * 18\. Have known history of HIV-1 or 2 with detectable viral load OR taking medications that may interfere with SN-38 metabolism. * 19.Severe infections within 4 weeks prior to be included in the study, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia. * 20.Patients with medical, mental, neurological or psychological condition which in the opinion of the investigator would not permit the patient to understand the patient information sheet or comply with study procedures. * 21\. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder; any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement; or prior pneumonectomy. * 22\. Treatment with systemic immunosuppressive medications * 23.Patients with uncontrolled comorbidities that may affect the clinical trial compliance. * 24.Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.

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Conditions

The condition(s) this trial relates to.

lung disorder non-small cell lung carcinoma

As listed by the trial registrant

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

Carcinoma, non-small-cell lung Lung diseases Resectable lung non-small cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

32 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Complejo Hospitalario Universitario de Vigo
RECRUITING

Vigo, Pontevedra, 36036, Spain
Consorci Sanitari de Terrassa
RECRUITING

Terrassa, Terrassa, 08227, Spain
Hospital Clínic De Barcelona
RECRUITING

Barcelona, Barcelona, 08036, Spain
Hospital Clínico San Carlos
RECRUITING

Madrid, Madrid, 28040, Spain
Hospital Clínico Universitario de Valladolid
RECRUITING

Valladolid, Valladolid, 47003, Spain
Hospital Clínico de Valencia
RECRUITING

Valencia, Valencia, 46010, Spain
Hospital De Basurto
RECRUITING

Bilbao, Bilbao, 48013, Spain
Hospital General Universitario de Alicante
RECRUITING

Alicante, Alicante, 03010, Spain
Hospital General de Elche
RECRUITING

Elche, Alicante, 03203, Spain
Hospital Miguel Servet
NOT_YET_RECRUITING

Zaragoza, Spain
Hospital Parc Taulí
RECRUITING

Barcelona, Barcelona, 08208, Spain
Hospital San Cecilio
RECRUITING

Granada, Spain
Hospital Santa María Nai
RECRUITING

Ourense, Ourense, 32005, Spain
Hospital Universitari Sant Joan de Reus
RECRUITING

Reus, Tarragona, 43204, Spain
Hospital Universitari Son Llatzer
RECRUITING

Palma de Mallorca, Palma de Mallorca, 07198, Spain
Hospital Universitari Vall d' Hebron
RECRUITING

Barcelona, Barcelona, 08035, Spain
Hospital Universitari de Gran Canària Doctor Negrín
RECRUITING

Las Palmas de Gran Canaria, Las Palmas, 35010, Spain
Hospital Universitario Fundación Jiménez Díaz
RECRUITING

Madrid, Madrid, 28040, Spain
Hospital Universitario Jerez De La Frontera
RECRUITING

Jerez de la Frontera, Cádiz, 11407, Spain
Hospital Universitario La Fe
RECRUITING

Valencia, Valencia, 46026, Spain
Hospital Universitario Lucus Augusti
RECRUITING

Lugo, Lugo, 27003, Spain
Hospital Universitario Nuestra Señora La Candelaria
RECRUITING

Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38009, Spain
Hospital Universitario Puerta de Hierro
RECRUITING

Majadahonda, Madrid, 28222, Spain
Hospital Universitario Salamanca
RECRUITING

Salamanca, Salamanca, 37007, Spain
Hospital Universitario de León
RECRUITING

León, León, 24071, Spain
Hospital Universitario la Paz
RECRUITING

Madrid, Madrid, 28046, Spain
Hospital Virgen del Rocío
RECRUITING

Seville, Sevilla, 41013, Spain
Hospital de Son Espases
RECRUITING

Palma de Mallorca, Mallorca, 07120, Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING

Barcelona, Barcelona, 08041, Spain
Hospitalario Universitario A Coruña
RECRUITING

A Coruña, La Coruña, 15006, Spain
ICO Badalona, Hospital Germans Trias i Pujol
RECRUITING

Badalona, Barcelona, 08916, Spain
ICO Hospitalet
RECRUITING

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

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