Non-Small Cell Lung CancerPhase 3IFEMNCT07877584
PD-1 Blockade Alone Versus in Combination With Chemotherapy as First Line Therapy in Females With Advanced NSCLC & PD-L1 Expression ≥50%
A Phase 3 study testing Pembrolizumab, Carboplatin (AUC 5) and Cisplatin (75 mg/m²) in people with Non-Small Cell Lung Cancer, run by German Cancer Research Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Pembrolizumab, Carboplatin (AUC 5) and Cisplatin (75 mg/m²)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 30 Nov 2033
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- ECOG performance status ≤2.
- At least one measurable lesion according to RECIST v1.1.
- Adequate hepatic, renal, and bone marrow function, confirmed within 14 days prior to randomization:
- Hematology (Hemoglobin ≥ 8.0 g/dL, Absolute neutrophil count (ANC) ≥ 2.0 × 10⁹/L, Total leukocyte count > 4.0 × 10⁹/L, Platelet count ≥ 100 × 10⁹/L, Serum albumin ≥ 3.0 g/dL) Renal function (Calculated creatinine clearance ≥ 60 mL/min (CKD-EPI equation, Serum creatinine ≤ 1.5 × ULN, Blood urea nitrogen (BUN) ≤ ULN) Hepatic function (Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for participants with Gilbert's syndrome, AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases present, Alkaline phosphatase ≤ 2.5 × ULN (≤ 5 × ULN if bone or liver metastases present Coagulation (INR and aPTT ≤ 1.5 × ULN unless on anticoagulant therapy (values within therapeutic range allowed)
- Female participants of childbearing potential (WOCBP) must use a highly effective contraceptive method (failure rate <1% per year) during treatment and for 6 months after the last dose. Participants who are postmenopausal or surgically sterile do not require contraception.
Who cannot join
- 1. 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.
- 2. Concurrent participation in another interventional clinical trial involving administration of an investigational medicinal product. Participation in non-interventional studies or registries is allowed.
- 3. 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).
- 4. Concurrent radiotherapy for cancer treatment, except limited palliative radiotherapy for non-target lesions.
- 5. Candidate for complete surgical removal of oligometastatic disease; participants refusing surgery/ablations may be included.
- 6. 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).
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- 7. Leptomeningeal disease. 8. History of interstitial lung disease. 9. Active infection requiring intravenous systemic therapy within 2 weeks prior to first study treatment. Participants with infections of CTCAE grade 1-2 that have been treated and clinically stabilized (e.g., uncomplicated urinary tract infection treated with oral antibiotics) may be included.
- 10. Known additional malignancy other than NSCLC, either untreated or requiring active treatment within the past 3 years.
- 11. Significant cardiovascular disease, including NYHA class ≥III congestive heart failure, clinically significant arrhythmias, or recent myocardial infarction (within 6 months). Left ventricular ejection fraction (LVEF) must be ≥50% (or ≥ institutional lower limit of normal) as assessed by echocardiogram or MUGA scan.
- 12. Active autoimmune disease or history of autoimmune or chronic inflammatory disorders requiring systemic treatment (e.g., corticosteroids, immunosuppressants) within the past 2 years, including but not limited to celiac disease, systemic lupus erythematosus, sarcoidosis, Wegener's granulomatosis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis.
- Note: Diverticulitis is considered under this criterion only if recurrent or chronic; uncomplicated diverticulosis is allowed.
- Exceptions:
- Vitiligo or alopecia
- Hypothyroidism stable on hormone replacement
- Controlled Type I diabetes mellitus on insulin
- Chronic skin conditions not requiring systemic therapy
- No active disease in the last 5 years (requires PI approval) 13. Current or prior use of immunosuppressive medication within 14 days before first pembrolizumab dose.
- Exceptions:
- Intranasal, inhaled, topical steroids, or local injections
- Systemic corticosteroids at doses ≤10 mg/day prednisone equivalent
- Steroids as premedication for hypersensitivity reactions 14. Treatment with systemic immunostimulatory agents (e.g., interferon, IL-2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to study treatment.
- 15. Live vaccine within 30 days prior to first dose of study treatment. 16. Known allergy or hypersensitivity to any component of the chemotherapy regimen or pembrolizumab.
- 17. Any co-existing medical condition that, in the investigator's judgment, substantially increases risk associated with participation.
- 18. Pregnant or breastfeeding women. 19. Participant incarcerated or involuntarily institutionalized by court order or authorities.
About this study
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. All patients will be randomly assigned to one of the two treatment strategies, with the primary endpoint being the time until disease progression. Additional analyses will evaluate survival and quality of life differences. This investigator-initiated trial, has the potential to reshape clinical practice and improve outcomes for women with lung cancer worldwide.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Pembrolizumab, Carboplatin (AUC 5), Cisplatin (75 mg/m²), Pemetrexed (500 mg/m²), nab-Paclitaxel (100 mg/m² )
- Keywords
- females, chemoimmunotherapy, Non-Small Cell Lung Cancer, Programmed Death-Ligand 1 (PD-L1) ≥ 50 %
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Pembrolizumab (200 mg intravenously, d1, q3W)
Carboplatin (AUC 5)Drug
Carboplatin (AUC 5), i.v., d1, q3W, for four cycles
Cisplatin (75 mg/m²)Drug
Cisplatin (75 mg/m²) , i.v., d1, q3W, four cycles
Pemetrexed (500 mg/m²)Drug
Pemetrexed (500 mg/m²), i.v., d1, q3W, for four cycles as combination chemoimmunotherapy, after as maintanance therapy with pembrolizumab
nab-Paclitaxel (100 mg/m² )Drug
nab-Paclitaxel (100 mg/m² ), i.v. on days 1, 8, and 15 (q3W), four cycles
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab (200 mg intravenously every 3 weeks) | Active comparator | Not described Receives: Drug: Pembrolizumab |
| Pembrolizumab (200 mg intravenously every 3 weeks) plus chemotherapy | Experimental | Pembrolizumab (200 mg intravenously every 3 weeks) plus chemotherapy for 4 cycles:
* For adenocarcinoma: Carboplatin (AUC 5) or Cisplatin (75 mg/m²) plus Pemetrexed (500 mg/m²), with optional maintenance therapy using Pemetrexed
* For squamous cell carcinoma: Carboplatin (AUC 5) plus nab-Paclitaxel (100 mg/m² on days 1, 8, and 15) Receives: Drug: Pembrolizumab; Drug: Carboplatin (AUC 5); Drug: Cisplatin (75 mg/m²); Drug: Pemetrexed (500 mg/m²); Drug: nab-Paclitaxel (100 mg/m² ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival (PFS) according to RECIST v1.1, defined as the time from randomization until documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first (composite variable strategy) assessed up to 24 months after LPI. Measurement will be based on imaging assessments at predefined intervals.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after the last patient is included in the study. (estimated 90 months from FPI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Nov 2033 (estimated)
- Study completion30 Nov 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 406 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877584
- Sponsor's protocol ID
- 2026-525387-18-00
- Other IDs
- 2026-525387-18-00
- Acronym
- IFEM
- Status last verified
- Oct 2026
- First submitted
- 27 Apr 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-1 Blockade Alone Versus in Combination With Chemotherapy as First Line Therapy in Females With Advanced NSCLC & PD-L1 Expression ≥50%
- ClinicalTrials.gov ID
- NCT07877584
- Acronym / sponsor ID
- IFEM / 2026-525387-18-00
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- females, chemoimmunotherapy, Non-Small Cell Lung Cancer, Programmed Death-Ligand 1 (PD-L1) ≥ 50 %
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- German Cancer Research CenterUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Nov 2033 (estimated)
- Study completion
- 30 Nov 2033 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. All patients will be randomly assigned to one of the two treatment strategies, with the primary endpoint being the time until disease progression. Additional analyses will evaluate survival and quality of life differences. This investigator-initiated trial, has the potential to reshape clinical practice and improve outcomes for women with lung cancer worldwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab (200 mg intravenously every 3 weeks) | Active comparator | Drug: Pembrolizumab |
| Pembrolizumab (200 mg intravenously every 3 weeks) plus chemotherapy | Experimental | Drug: Pembrolizumab, Drug: Carboplatin (AUC 5), Drug: Cisplatin (75 mg/m²), Drug: Pemetrexed (500 mg/m²), Drug: nab-Paclitaxel (100 mg/m² )Pembrolizumab (200 mg intravenously every 3 weeks) plus chemotherapy for 4 cycles: * For adenocarcinoma: Carboplatin (AUC 5) or Cisplatin (75 mg/m²) plus Pemetrexed (500 mg/m²), with optional maintenance therapy using Pemetrexed * For squamous cell carcinoma: Carboplatin (AUC 5) plus nab-Paclitaxel (100 mg/m² on days 1, 8, and 15) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (24 listed)
- 1. 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.
- 2. Concurrent participation in another interventional clinical trial involving administration of an investigational medicinal product. Participation in non-interventional studies or registries is allowed.
- 3. 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).
- 4. Concurrent radiotherapy for cancer treatment, except limited palliative radiotherapy for non-target lesions.
- 5. Candidate for complete surgical removal of oligometastatic disease; participants refusing surgery/ablations may be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabPembrolizumab (200 mg intravenously, d1, q3W) | Drug | Pembrolizumab (200 mg intravenously every 3 weeks), Pembrolizumab (200 mg intravenously every 3 weeks) plus chemotherapy |
| Carboplatin (AUC 5)Carboplatin (AUC 5), i.v., d1, q3W, for four cycles | Drug | Pembrolizumab (200 mg intravenously every 3 weeks) plus chemotherapy |
| Cisplatin (75 mg/m²)Cisplatin (75 mg/m²) , i.v., d1, q3W, four cycles | Drug | Pembrolizumab (200 mg intravenously every 3 weeks) plus chemotherapy |
| Pemetrexed (500 mg/m²)Pemetrexed (500 mg/m²), i.v., d1, q3W, for four cycles as combination chemoimmunotherapy, after as maintanance therapy with pembrolizumab | Drug | Pembrolizumab (200 mg intravenously every 3 weeks) plus chemotherapy |
| nab-Paclitaxel (100 mg/m² )nab-Paclitaxel (100 mg/m² ), i.v. on days 1, 8, and 15 (q3W), four cycles | Drug | Pembrolizumab (200 mg intravenously every 3 weeks) plus chemotherapy |
Primary outcome
Progression-free survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after the last patient is included in the study. (estimated 90 months from FPI)
Progression-free survival (PFS) according to RECIST v1.1, defined as the time from randomization until documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first (composite variable strategy) assessed up to 24 months after LPI. Measurement will be based on imaging assessments at predefined intervals.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pembrolizumab, Carboplatin (AUC 5) and Cisplatin (75 mg/m²) in people with Non-Small Cell Lung Cancer, run by German Cancer Research Center.
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 11 inclusion and 24 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: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after the last patient is included in the study. (estimated 90 months from FPI)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.