Recruiting PHASE3 Lung Diseases

New treatment option for Lung Diseases

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.

ClinicalTrials.gov ID: NCT06431633

What this study is testing

What is Zimberelimab?

Zimberelimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lung diseases.

Also referred to as anti-PD-1 monoclonal antibody AB122.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing: 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.

Phase 3: a large, late-stage study
Time commitment: about 1 years
Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

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...
3\. Complete surgical resection (R0) of the primary NSCLC is also essential. Surgeons are strongly advised to dissect or obtain samples of all...
4\. The surgical intervention may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy, as determined by the responsible surgeon...
5\. Only patients that do not achieve pathological complete response (pCR) seen in the surgical piece after neoadjuvant therapy are eligible.

You likely can't join if

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...
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...

See the full eligibility criteria

Who can 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...
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...
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...
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...
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

What rules you out

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...
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...
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...
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...
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...
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...
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.

The study team makes the final eligibility decision.

Where it's taking place

Alicante, Alicante, Spain
Elche, Alicante, Spain
Badalona, Barcelona, Spain
Barcelona, Barcelona, Spain
L'Hospitalet de Llobregat, Barcelona, Spain
Bilbao, Bilbao, Spain
Jerez de la Frontera, Cádiz, Spain
A Coruña, La Coruña, Spain
Las Palmas de Gran Canaria, Las Palmas, Spain
León, León, Spain
Lugo, Lugo, Spain
Madrid, Madrid, Spain
Majadahonda, Madrid, Spain
Palma de Mallorca, Mallorca, Spain
Ourense, Ourense, Spain
Palma de Mallorca, Palma de Mallorca, Spain
Vigo, Pontevedra, Spain
Salamanca, Salamanca, Spain
Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain
Seville, Sevilla, Spain

+ 6 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The study runs about 1 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Alicante, Alicante, Spain; Elche, Alicante, Spain; Badalona, Barcelona, Spain; Barcelona, Barcelona, Spain; L'Hospitalet de Llobregat, Barcelona, Spain; Bilbao, Bilbao, Spain and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

Obesity Type 2 diabetes Type 1 diabetes Prediabetes Weight loss Metabolic syndrome High cholesterol High triglycerides High blood pressure PCOS Hypothyroidism Thyroid disease Gout Fatty liver disease (NAFLD/NASH)Heart failure Coronary artery disease

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.