Not recruitingRare disease

Study of Sacituzumab Govitecan, Pembrolizumab, and a Platinum Drug Combination for Advanced Non-Small Cell Lung Cancer Patients Without Genomic Alterations

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for , a type of lung cancer that is common and can be advanced or spread to other parts of the body. The study is exploring the use of a medication called , which is being tested in combination with other treatments. These include , a medication that helps the immune system fight cancer, and platinum-based drugs like and , which are commonly used in chemotherapy to kill cancer cells.

The purpose of the study is to evaluate how well these combinations work in treating patients with advanced or metastatic NSCLC who do not have specific genetic changes that can be targeted with other treatments. The study will involve patients receiving these medications through an infusion, which means the drugs are given directly into the bloodstream through a vein. Some patients may receive a placebo, which is a substance with no active medication, to compare the effects of the actual drugs.

Participants in the study will receive treatment over a period of time, with regular check-ups to monitor their health and the cancer's response to the treatment. The study aims to find out how effective the treatment combinations are in shrinking the cancer or stopping it from growing, as well as to determine the best dose of when used with and a platinum drug. The study will also look at the safety of these treatments and any side effects that may occur.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.
Tests may include imaging studies like CT or MRI to measure disease status, and blood tests to ensure adequate organ function.
Step 2
Treatment initiation
The treatment phase begins with the administration of medications through intravenous use. The medications include cisplatin, carboplatin, pembrolizumab, and sacituzumab govitecan.
The specific combination and dosage depend on the treatment group assigned. The goal is to evaluate the effectiveness of these combinations in treating advanced or metastatic non-small-cell lung cancer.
Step 3
Monitoring and follow-up
Regular monitoring is conducted to assess the response to treatment. This includes periodic imaging studies and laboratory tests.
The primary focus is on measuring the objective response rate, which is the proportion of patients who experience a significant reduction in tumor size.
Step 4
Safety evaluation
Safety evaluations are performed to monitor for any adverse effects related to the treatment. This includes tracking any dose-limiting toxicities during the initial 21 days of treatment.
The incidence of treatment-emergent adverse events and laboratory abnormalities is also recorded.
Step 5
Completion and final assessment
Upon completion of the treatment period, a final assessment is conducted to evaluate overall survival and progression-free survival.
The duration of response and disease control rate are also analyzed to determine the long-term benefits of the treatment.

Who can join the trial?

21 criteria

Patients must be **18 years of age or older** and able to understand and give written consent to participate.
Patients with **HIV** must be on antiretroviral therapy (ART) and have a well-controlled infection, meaning:
- CD4 + T-cell count greater than 350 cells/mm³.
- HIV RNA level below 50 copies/mL for at least 12 weeks before screening.
- Stable ART regimen for at least 4 weeks before joining the study.
- ART regimen must not interfere with SN-38 metabolism.
- Male and female patients who can have children and engage in heterosexual intercourse must agree to use specific methods of **contraception**.
- Patients must have a **life expectancy** of at least 3 months.
- Patients must have **non-small cell lung cancer (NSCLC)** that meets specific criteria:
  - Stage IV NSCLC at the time of enrollment.
  - Negative test results for EGFR and ALK.
  - No known genomic changes in ROS1, NTRK, BRAF, RET mutations, or other treatable driver genes.
  - Provide tumor tissue from non-radiated areas for testing.
  - Patients must have **measurable disease** by CT or MRI as per specific criteria. Tumor lesions in previously treated areas are measurable if they show progression.
  - No prior systemic treatment for **metastatic NSCLC**. Patients who had adjuvant or neoadjuvant therapy are eligible if it was completed at least 6 months before the development of metastatic disease.
  - **ECOG performance status** score of 0 or 1, which is a measure of the patient's daily living abilities, assessed within 7 days before treatment.
  - **Adequate blood counts** without support from transfusions or growth factors within 10 days of starting the study drug:
    
    Hemoglobin of at least 9 g/dL.
    Absolute neutrophil count (ANC) of at least 1500/mm³.
    Platelets of at least 100,000/μL.
    **Adequate liver function**:
    
    Bilirubin level 1.5 times the upper limit of normal (ULN) or less.
    AST and ALT levels 2.5 times ULN or less, or 5 times ULN if liver metastases are present.
    Serum albumin greater than 3 g/dL.
    **Creatinine clearance** of at least 30 mL/min, which is a measure of kidney function. For patients in certain groups, it must be at least 60 mL/min.

Who cannot join the trial?

5 criteria

Patients with other types of cancer besides non-small cell lung cancer cannot participate. Non-small cell lung cancer is a type of lung cancer.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial groups cannot participate.
Patients who are not female or male cannot participate, as the study includes both genders.
Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to protect their own interests.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Goethe University Frankfurt
Verified
Frankfurt, Germany
Hospital Clinic De Barcelona
Verified
Barcelona, Spain
Hospital General Universitario Gregorio Maranon
Verified
Madrid, Spain

Trial locations

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Investigated drugs

Sacituzumab Govitecan
is a medication being studied for its potential to treat advanced or metastatic non-small-cell lung cancer. It is used in combination with other treatments to see if it can help improve outcomes for patients who do not have specific genetic changes in their cancer.
Pembrolizumab
is an immunotherapy drug that helps the body's immune system fight cancer. It is being tested in combination with other medications to see if it can enhance the treatment of non-small-cell lung cancer.
Platinum Agent
refers to a type of chemotherapy drug that contains platinum. These drugs are used to damage the DNA of cancer cells, which can help stop the cancer from growing and spreading. In this trial, a platinum agent is combined with other treatments to evaluate its effectiveness in treating non-small-cell lung cancer.

What is already known about the treatment

Sacituzumab Govitecan
This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic non-small cell lung cancer. It is not yet widely used in standard medical practice but shows promise in ongoing research. Sacituzumab Govitecan is primarily indicated for cancers that do not have specific genetic mutations that can be targeted by other treatments. It works by delivering a chemotherapy agent directly to cancer cells, using an antibody that binds to a protein commonly found on the surface of these cells. This targeted approach helps to minimize damage to healthy cells. It is classified as an antibody-drug conjugate.
Pembrolizumab
This medication is administered intravenously and is currently used in combination with other agents in clinical trials for treating advanced or metastatic non-small cell lung cancer. It is already approved for use in various cancers and is well-documented in medical literature. Pembrolizumab is indicated for cancers that do not have specific genetic mutations. It works by blocking a protein on immune cells, allowing them to better recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor.
Platinum Agent
This class of medication is administered intravenously and is being studied in combination with other drugs for the treatment of advanced or metastatic non-small cell lung cancer. Platinum agents are well-established in medical practice and literature for their role in cancer treatment. They are indicated for a variety of cancers and work by causing damage to the DNA of cancer cells, preventing them from dividing and growing. These agents are classified as alkylating agents.

Investigated diseases

Non-small cell lung cancer – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. The disease typically starts in the tissues of the lungs and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms. Early stages may not show noticeable symptoms, making it challenging to detect without medical screening.