Actively Recruiting
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.
Led by Fundación GECP · Updated on 2026-04-30
129
Participants Needed
30
Research Sites
355 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. 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.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with primary non-small cell lung cancer confirmed by tissue analysis
- Postoperative stage IB, IIA, IIB, IIIA, or IIIB (N2) lung cancer according to standard staging manual
- Complete surgical removal (R0 resection) of the cancer
- Surgery included lobectomy, sleeve resection, bilobectomy, or pneumonectomy; segmentectomy or wedge resection only if R0 confirmed
- Did not achieve complete pathological response after neoadjuvant therapy
- Received preoperative platinum-based chemotherapy plus immunotherapy
- No preoperative, postoperative, or planned radiation therapy allowed
- At least 3 weeks since surgery and treatment to start between 3 and 10 weeks post-surgery
- Eastern Cooperative Oncology Group performance status 0 or 1
- Age 18 years or older
- Local analysis of PDL1 value available before randomization
- PET-CT and brain CT confirming no distant disease before randomization
- Adequate blood and organ function
- Provided informed consent
- For women of childbearing potential, agreement to use highly effective contraception
- For men with female partners of childbearing potential, agreement to use highly effective contraception
- Oral contraception combined with additional contraceptive method
- Negative pregnancy test within 14 days before starting study drug for women who are not postmenopausal or surgically sterile
- Able to comply with treatment and follow-up
- Life expectancy greater than 12 weeks
You will not qualify if you...
- History of other cancers except treated non-melanotic skin cancer or in situ cancers treated curatively without risk of relapse for over 3 years
- T4 tumors invading heart, great vessels, carina, trachea, esophagus, or spine
- Known ALK translocation, STK11, or KEAP1 mutations
- Presence of EGFR mutations in adenocarcinoma NSCLC
- Mixed small cell and non-small cell lung cancer, carcinoid lung tumor, or large cell neuroendocrine carcinoma
- Active inflammatory bowel disease or gastrointestinal perforation within 6 months
- Received live attenuated vaccines within 30 days prior to randomization
- History of primary immunodeficiency, organ transplant, recent immunosuppressive drug use, or severe immune-related toxicity
- Active or uncontrolled infections or serious medical conditions
- Untreated or uncontrolled cardiovascular disease or symptomatic heart dysfunction
- Pregnant or breastfeeding women
- Incomplete surgical resection (R0) not confirmed
- Active, known, or suspected autoimmune disease except specific permitted conditions
- Need for systemic corticosteroids or immunosuppressive treatment within 14 days before randomization
- Active hepatitis B or C infection with detectable viral load
- Allergy or hypersensitivity to study drugs
- Pleural or pericardial effusion unless proven non-metastatic
- HIV infection with detectable viral load or medications interfering with study drug metabolism
- Severe infections within 4 weeks before study
- Conditions impairing understanding or compliance
- Severe lung problems due to other diseases or prior lung removal
- Use of systemic immunosuppressive medications
- Uncontrolled other medical conditions
- Sexually active men and women of childbearing potential unwilling to use effective contraception
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
Hospital General Universitario de Alicante
Alicante, Alicante, Spain, 03010
Actively Recruiting
2
Hospital General de Elche
Elche, Alicante, Spain, 03203
Actively Recruiting
3
ICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Actively Recruiting
4
Hospital Universitari Vall d' Hebron
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
5
Hospital Clínic De Barcelona
Barcelona, Barcelona, Spain, 08036
Actively Recruiting
6
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain, 08041
Actively Recruiting
7
Hospital Parc Taulí
Barcelona, Barcelona, Spain, 08208
Actively Recruiting
8
ICO Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
9
Hospital De Basurto
Bilbao, Bilbao, Spain, 48013
Actively Recruiting
10
Hospital Universitario Jerez De La Frontera
Jerez de la Frontera, Cádiz, Spain, 11407
Actively Recruiting
11
Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain, 15006
Actively Recruiting
12
Hospital Universitari de Gran Canària Doctor Negrín
Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
Actively Recruiting
13
Hospital Universitario de León
León, León, Spain, 24071
Actively Recruiting
14
Hospital Universitario Lucus Augusti
Lugo, Lugo, Spain, 27003
Actively Recruiting
15
Hospital Clínico San Carlos
Madrid, Madrid, Spain, 28040
Actively Recruiting
16
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain, 28040
Actively Recruiting
17
Hospital Universitario la Paz
Madrid, Madrid, Spain, 28046
Actively Recruiting
18
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
19
Hospital de Son Espases
Palma de Mallorca, Mallorca, Spain, 07120
Actively Recruiting
20
Hospital Santa María Nai
Ourense, Ourense, Spain, 32005
Actively Recruiting
21
Hospital Universitari Son Llatzer
Palma de Mallorca, Palma de Mallorca, Spain, 07198
Actively Recruiting
22
Complejo Hospitalario Universitario de Vigo
Vigo, Pontevedra, Spain, 36036
Actively Recruiting
23
Hospital Universitario Salamanca
Salamanca, Salamanca, Spain, 37007
Actively Recruiting
24
Hospital Universitario Nuestra Señora La Candelaria
Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain, 38009
Actively Recruiting
25
Hospital Virgen del Rocío
Seville, Sevilla, Spain, 41013
Actively Recruiting
26
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, Spain, 43204
Actively Recruiting
27
Consorci Sanitari de Terrassa
Terrassa, Terrassa, Spain, 08227
Actively Recruiting
28
Hospital Clínico de Valencia
Valencia, Valencia, Spain, 46010
Actively Recruiting
29
Hospital Universitario La Fe
Valencia, Valencia, Spain, 46026
Actively Recruiting
30
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, Spain, 47003
Actively Recruiting
Research Team
E
Eva Pereira
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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