TrialBridgeNCT07877584
PD-1 Blockade Alone Versus in Combination With Chemotherapy as First Line Therapy in Females With Advanced NSCLC & PD-L1 Expression ≥50%
Not Yet Recruiting · Phase 3 · German Cancer Research Center · registry updated 2026-10-16
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
While documented gender differences exist in drug efficacy and safety, men and women are often treated equally due to the absence of gender-specific clinical trials and approvals. Immune checkpoint blockade is used to enhance the immune system's ability to combat cancer cells and is approved for stage IV non-small cell lung cancer (NSCLC) patients with over 50% PD-L1 expression on tumor surfaces. However, uncertainty remains regarding whether immunotherapy alone or in combination with chemotherapy yields better results. Although both treatment strategies are approved, head-to-head evidence comparing these approaches is lacking. Large trials indicate that women derive less benefit from immunotherapy alone compared to men, while benefiting more from a combination therapy. However, women are often still treated with immunotherapy alone due to a lack of prospective clinical trial evidence supporting combined treatment's superiority. This world's first gender-specific trial aims to determine whether combined treatment is better than immunotherapy alone for female patients....
Inclusion
- Ability to understand the nature, significance, and individual consequences of the clinical trial.
- Written informed consent obtained prior to any trial-related procedures.
- Female participant aged ≥18 years at the time of signing the informed consent form.
- Histologically or cytologically confirmed stage IV NSCLC (squamous cell carcinoma or adenocarcinoma).
- Negative molecular testing for EGFR, ALK, and ROS1 alterations (tested locally).
- PD-L1 tumor proportion score (TPS) ≥50%, tested locally by QUiP®-certified immunohistochemistry.
Exclusion
- \. Mixed histology including any small-cell component. Participants with mixed non-small cell histology (e.g., squamous and non-squamous) may be eligible only if the predominant component (≥50%) is squamous cell carcinoma or adenocarcinoma.
- \. Concurrent participation in another interventional clinical trial involving administration of an investigational medicinal product. Participation in non-interventional studies or registries is allowed.
- \. Prior systemic treatment for metastatic or locally advanced disease or prior PD-1/PD-L1 immunotherapies (including CD137 agonists or immune checkpoint inhibitors such as anti-CTLA-4, anti-TIGIT, anti-PD-1, or anti-PD-L1 antibodies).
- \. Concurrent radiotherapy for cancer treatment, except limited palliative radiotherapy for non-target lesions.
- \. Candidate for complete surgical removal of oligometastatic disease; participants refusing surgery/ablations may be included.
- \. Symptomatic or neurologically unstable CNS metastases or requiring increasing doses of steroids to manage CNS symptoms within 2 weeks prior to study entry (maximum acceptable dose: ≤10 mg prednisolone).