AzTrials
AzTrials

Lung DiseasesPhase 3ARIANNCT06431633

Study of Treatment With Sacituzumab and Zimberelimab for Patients With Lung Cancer Confined to the Chest and Previously Operated on Who Were Not Disease-free.

A Phase 3 study testing Zimberelimab, Sacituzumab govitecan and Cisplatin in people with Lung Diseases and Carcinoma, Non-Small-Cell Lung, run by Fundación GECP at 32 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Open-label, phase III, randomized, stratified (PDL1- vs PDL1+), 3 arms, multicenter clinical trial. 129 resected patients (43 per arm) with stage from IB to IIIA and IIIB (N2) non-small cell lung cancer that do not achieve pathologic complete response (pCR) after neoadjuvant treatment. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Zimberelimab, Sacituzumab govitecan and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
32 sitesSpain
Study dates
4 Feb 2025to 30 Nov 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • 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.
Show all 20Show fewer
  • 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

Who cannot join

  • 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.
Show all 26Show fewer
  • 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.

Trial locations and contacts

32 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Eva Pereira contact

+34 934302006

gecp@gecp.org

32 sites in 1 country

Spain32 sites, 32 recruiting

  • Hospitalario Universitario A Coruña

    A Coruña, La Coruña, 15006

    Rosario García Campelo, MD

    Rosario García Campelo, MD

    Recruiting

  • Hospital General Universitario de Alicante

    Alicante, Alicante, 03010

    Bartomeu Massuti, MD

    Bartomeu Massuti, MD

    Recruiting

  • ICO Badalona, Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

    Marta Domenech, MD

    Marta Domenech, MD

    Recruiting

  • Hospital Universitari Vall d' Hebron

    Barcelona, Barcelona, 08035

    Alex Martínez, MD

    Alex Martínez, MD

    Recruiting

  • Hospital Clínic De Barcelona

    Barcelona, Barcelona, 08036

    Noemí Reguart

    Noemí Reguart, MD

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08041

    Andres Barba, MD

    Andres Barba, MD

    Recruiting

  • Hospital Parc Taulí

    Barcelona, Barcelona, 08208

    Laia Vilà, MD

    Laia Vilà, MD

    Recruiting

  • Hospital De Basurto

    Bilbao, Bilbao, 48013

    Mª Ángeles Sala, MD

    Mª Ángeles Sala, MD

    Recruiting

  • Hospital General de Elche

    Elche, Alicante, 03203

    Miguel Borregón Rivilla, MD

    Miguel Borregón Rivilla, MD

    Recruiting

  • Hospital San Cecilio

    Granada

    Silvia Sequero, MD

    Recruiting

  • Hospital Universitario Jerez De La Frontera

    Jerez de la Frontera, Cádiz, 11407

    Mª Ángeles Moreno, MD

    Mª Ángeles Moreno, MD

    Recruiting

  • ICO Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

    Ernest Nadal, MD

    Ernest Nadal, MD

    Recruiting

  • Hospital Universitari de Gran Canària Doctor Negrín

    Las Palmas de Gran Canaria, Las Palmas, 35010

    David Aguiar Bujanda, MD

    David Aguiar Bujanda

    Recruiting

  • Hospital Universitario de León

    León, León, 24071

    Soledad Medina, MD

    Soledad Medina, MD

    Recruiting

  • Hospital Universitario Lucus Augusti

    Lugo, Lugo, 27003

    Begoña Campos, MD

    Begoña Campos, MD

    Recruiting

  • Hospital Clínico San Carlos

    Madrid, Madrid, 28040

    Monica Antoñanzas, MD

    Monica Antoñanzas, MD

    Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, Madrid, 28040

    Manuel Dómine, MD

    Manuel Dómine, MD

    Recruiting

  • Hospital Universitario la Paz

    Madrid, Madrid, 28046

    Javier De Castro, MD

    Javier De Castro, MD

    Recruiting

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

    Mariano Provencio, MD

    Mariano Provencio, MD

    Recruiting

  • Hospital Santa María Nai

    Ourense, Ourense, 32005

    Karmele Areses, MD

    Karmele Areses

    Recruiting

  • Hospital de Son Espases

    Palma de Mallorca, Mallorca, 07120

    Aitor Azkárate Martínez, MD

    Aitor Azkárate Martínez, MD

    Recruiting

  • Hospital Universitari Son Llatzer

    Palma de Mallorca, Palma de Mallorca, 07198

    Juan Coves Sarto, MD

    Juan Coves Sarto, MD

    Recruiting

  • Hospital Universitari Sant Joan de Reus

    Reus, Tarragona, 43204

    Clara Lucía Gozálvez, MD

    Clara Lucía Gozálvez, MD

    Recruiting

  • Hospital Universitario Salamanca

    Salamanca, Salamanca, 37007

    Alejandro Olivares Hernández, MD

    Alejandro Olivares Hernández, MD

    Recruiting

  • Hospital Universitario Nuestra Señora La Candelaria

    Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38009

    Karla Mercedes Medina, MD

    Karla Mercedes Medina, MD

    Recruiting

  • Hospital Virgen del Rocío

    Seville, Sevilla, 41013

    Reyes Bernabé, MD

    Reyes Bernabé, MD

    Recruiting

  • Consorci Sanitari de Terrassa

    Terrassa, Terrassa, 08227

    Remei Blanco, MD

    Remei Blanco, MD

    Recruiting

  • Hospital Clínico de Valencia

    Valencia, Valencia, 46010

    Amelia Insa, MD

    Amelia Insa, MD

    Recruiting

  • Hospital Universitario La Fe

    Valencia, Valencia, 46026

    Oscar Juan-Vidal, MD

    Oscar Juan-Vidal, MD

    Recruiting

  • Hospital Clínico Universitario de Valladolid

    Valladolid, Valladolid, 47003

    Rafael López, MD

    Rafael López, MD

    Recruiting

  • Complejo Hospitalario Universitario de Vigo

    Vigo, Pontevedra, 36036

    Gerardo Huidobro, MD

    Gerardo Huidobro, MD

    Recruiting

  • Hospital Miguel Servet

    Zaragoza

    Joaquin Gimeno, MD

    Not yet recruiting

Other trials in Spain

About this study

Official title: A Phase III Clinical Trial of Adjuvant Treatment With Sacituzumab and Zimberelimab for Stage IB-IIIA-IIIB(N2) Previously Resected (R0) Non-small Cell Lung Cancer Patients That Did Not Achieve Pathological Complete Response After Neoadjuvant treatment_ARIAN

Open-label, phase III, randomized, stratified (PDL1- vs PDL1+), 3 arms, multicenter clinical trial.

129 resected patients (43 per arm) with stage from IB to IIIA and IIIB (N2) non-small cell lung cancer that do not achieve pathologic complete response (pCR) after neoadjuvant treatment.

Read more

This clinical trial has 3 arms of treatment. ARM 1: Observation 10 months, ARM 2: treatment with immunotherapy (Zimberelimab) for 13 cycles and ARM 3: treatment with Sacituzumab Govitecan and Zimberelimab for 8 cycles and Zimberelimab monotherapy for 5 cycles.

The primary objective is to evaluate the disease-free survival (DFS): defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time.

Patient accrual is expected to be completed within 2 years, treatment is planned to extend during 1 years and the patients will be followed up for 2 years. The study will end once survival follow-up has concluded.

Read the detailed description

This is an open-label, phase III, randomized, stratified (PDL1- vs PDL1+), 3 arms, multicenter clinical trial.

Patients stage IB to IIIA-IIIB (T3N2) after surgical resection if they did not achieve a pathological com-plete response (pCR) will be randomized 1:1:1 to:

  • ARM 1: Observational Arm for 10 months
  • ARM 2: Immunotherapy (Zimberelimab) treatment for 13 cycles, Q3W
  • ARM 3: Sacituzumab Govitecan + Zimberelimab Q3W for 8 cycles + Zimberelimab Q3W for 5 cycles. Patients will receive 8 cycles of the combination and 5 cycles of Zimberelimab monotherapy.

The primary objective is to evaluate the disease-free survival (DFS): defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time.

Disease Free survival (DFS): The time from random assignment to cancer recurrence or death from any cause.

Secondary objectives:

  • Overall survival (OS): at 12, 24 and 36 months after the start of adjuvant treatment
  • Safety and tolerability of the combination of Sacituzumab Govitecan + Zimberelimab according to CTCAE v5.0.

Exploratory objectives

  • To evaluate whether there is a significant association between change in levels of ctDNA between baseline and after adjuvant treatment and OS and DFS.

The total trial duration will be 7 years approximately. Approval-start up: 4-6 months. Patient accrual is expected to be completed within 2 years. One year of treatment and 3 years of follow up, and close-out: 4-6 months. The study will end once survival follow-up has concluded

Being tested
Zimberelimab, Sacituzumab govitecan, Cisplatin, Carboplatin
Medical subject headings
Lung Diseases, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • ZimberelimabDrug

    Also called anti-PD-1 monoclonal antibody AB122

    Zimberelimab is a fully human IgG4 monoclonal antibody targeting human PD-1. PD-1 is a type I transmembrane protein that is part of the immunoglobulin gene superfamily and the CD28 family of cell surface receptors. PD-1 is an inhibitory immune checkpoint protein that is expressed on activated B cells, T cells, and myeloid cells, and it plays a key role in limiting the activity of effector T cells.

    Zimberelimab is formulated at 30 mg/mL in a buffer solution containing histidine/histidine-HCl buffer solution, sucrose, sodium chloride, and polysorbate 80, at pH 5.5. The investigational product is supplied as a vial contains 120 mg of active Zimberelimab at a concentration of 30mg/mL.

    No premedication nor profilaxis is needed before Zimberelimab administration. Zimberelimab doses are administered by IV infusion over 60 minutes, followed by a 30- to 60-minute observation period, on D1 of each 21-day cycle.

  • Sacituzumab govitecanDrug

    Also called Trodelvy

    Sacituzumab govitecan (SG) is an ADC composed of the following 3 components:

    • The humanized monoclonal antibody hRS7 IgG1κ, which binds to Trop-2, a transmembrane calcium signal transducer that is overexpressed in many epithelial cancers.
    • The camptothecin-derived agent SN-38, a topoisomerase I inhibitor. o A hydrolyzable linker, with the company designation as CL2A that links the humanized monoclonal antibody to SN-38.

    Sacituzumab govitecan is approved globally for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) and HR+ breast cancer.

  • CisplatinDrug

    Also called Platinol

    Cisplatin-based adjuvant chemotherapy

    Cisplatin - CAS 15663-27-1, is a platinum coordination complex with potent anti-neoplastic activity. Induces apoptosis in cancer cells, possibly via caspase-3 activation.

  • CarboplatinDrug

    Also called Paraplatin

    Cisplatin-based adjuvant chemotherapy Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) plating. Stability: 24 hours at ambient temperature in 5% glucose, glucosamine or physiologic saline. It is recommended not to dilute with chlorinated solutions for this could affect the carboplatin. Route of administration: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of each center. Other Name: ATC code: L01XA02

Study groups in NCT06431633
Study groupRoleWhat they receive
ARM 1: Observation-investigator decisionActive comparatorPatients randomized in this arm will be in observation for 10 months. It is allowed to administer adjuvant treatment according to investigator criteria. Immunotherapy is not allowed in this arm, only chemotherapy treatment is allowed.
Receives: Drug: Cisplatin; Drug: Carboplatin
ARM 2: Immunotherapy. Zimberelimab treatment for 13 cyclesExperimentalAdjuvant treatment with Zimberelimab will start between the 3rd to the 10th week from surgery. 13 cycles will be administered in total. Cycles will be administered in 21-day intervals (Q3W). Zimberelimab: day 1 360 mg IV Q3W (13 cycles)
Receives: Drug: Zimberelimab
ARM 3: Sacituzumab Govitecan + Zimberelimab for 8 cycles + Zimberelimab for 5 cyclesExperimentalSacituzumab Govitecan: day 1 and 8; 10mg/Kg IV Q3W Zimberelimab: day 1 360 mg IV Q3W Treatment sequence: Adjuvant treatment will start between the 3rd to the 10th week from surgery. 13 cycles will be administered in total. Cycles will be administered in 21-day intervals (Q3W). Patients will receive 8 cycles of Sacituzumab Govitecan + Zimberelimab and 5 cycles of Zimberelimab monotherapy.
Receives: Drug: Zimberelimab; Drug: Sacituzumab govitecan

What is being measured

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

  1. Disease free survival

    Defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time.

    Measured: The time from random assignment to cancer recurrence or death from any cause, assessed up to 36 months

Secondary outcomes (2)

  1. Overall survival

    defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive.

    Measured: To evaluate at 12, 24 and 36 months after the start of adjuvant treatment

  2. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.

    Measured: From the subject's written consent to participate in the study through 180 days after the final administration of the drug

Timeline

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

  1. First posted28 May 2024
  2. Study start4 Feb 2025
  3. Primary completion30 Nov 2031 (estimated)
  4. Study completion30 Nov 2031 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
129 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06431633
Sponsor's protocol ID
GECP 23/03_ARIAN
Other IDs
2024-512960-75-00
Acronym
ARIAN
Status last verified
May 2026
First submitted
22 May 2024
Last updated
18 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zimberelimab, Sacituzumab govitecan and Cisplatin in people with Lung Diseases and Carcinoma, Non-Small-Cell Lung, run by Fundación GECP at 32 sites in Spain.

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 20 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Eva Pereira (+34 934302006, gecp@gecp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease free survival (time frame: The time from random assignment to cancer recurrence or death from any cause, assessed up to 36 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 NCT06431633.

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 18 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in