Prospective Trial to Assess Real-world Outcomes and Predictive Biomarkers of Response to Pembrolizumab With or Without Chemotherapy in Black Patients With NSCLC

Plain English Summary

Prospective Trial Assessing Real World Outcomes Response to Pembro in Black Patients w/ NSCLC is a Phase 2 clinical trial sponsored by H. Lee Moffitt Cancer Center and Research Institute studying Non-small Cell Lung Cancer. This trial tests how well pembrolizumab works, alone or with chemotherapy, in Black patients with advanced non-small cell lung cancer. It is for Black patients aged 18 and older with advanced non-small cell lung cancer who have not received prior treatment for this stage of the disease. Participation involves receiving study treatment, regular medical check-ups, and providing blood samples. Standard treatment options for advanced lung cancer include chemotherapy, targeted therapy (if specific mutations are present), and immunotherapy. The trial aims to enroll 318 participants.

Official Summary

This is a non-registrational, cohort study enrolling eligible Black patients diagnosed with histologically or cytologically, advanced/metastatic NSCLC without known EGFR/ALK/ROS1 tumor mutations, and who are ≥ 18 years of age, ECOG performance status 0-2, and may have detectable ctDNA at baseline.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are Black, 18 or older, have advanced non-small cell lung cancer, and have not been treated for this stage of cancer. You cannot join if you have known EGFR, ALK, or ROS1 mutations, or if you have active autoimmune disease requiring systemic treatment. Certain prior treatments for earlier stages of lung cancer may be allowed if the disease has returned 6 months or more after finishing treatment. Your general health and organ function must be adequate for treatment. This trial is studying Non-small Cell Lung Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures, such as overall survival and progression-free survival, will tell us how long patients live and how long their cancer stays under control with the study treatments. The specific primary outcome measures are: Cohort 1: Real World Overall Survival (rwOS) (Up to 36 Months); Cohort 2 Arm A: Progression Free Survival (PFS) (Up to 36 Months); Cohort 2 Arm B: Progression Free Survival (PFS) (Up to 36 Months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a gap in understanding how immunotherapy and chemotherapy combinations work specifically in Black patients with lung cancer, a group often underrepresented in research. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Non-small Cell Lung Cancer, where improved treatment options are needed.

Investor Insight

This Phase 2 trial focuses on a specific patient population, suggesting a targeted approach to improving treatment outcomes for Black patients with NSCLC, potentially leading to new treatment guidelin Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific chemotherapy drugs used, the schedule of treatments, and potential side effects. Be prepared for regular clinic visits for treatment, monitoring, and blood draws. Understand that this trial involves investigational treatment, and its effectiveness and safety are still being studied. This trial is currently recruiting participants. The trial is being conducted at 5 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 318 participants

Interventions

• DRUG: Cisplatin — Given on day 1 of every 21-day cycle.
• DRUG: Carboplatin — Given on day 1 of every 21-day cycle.
• DRUG: Pemetrexed — Given on day 1 of every 21-day cycle.
• DRUG: Pembrolizumab — Given on day 1 of every 21-day cycle. After cycle 4 is given every 6 weeks.
• DRUG: Abraxane — Given on days 1, 8, and 15 of each 21-day cycle.

Primary Outcomes

• Cohort 1: Real World Overall Survival (rwOS) (Up to 36 Months)
• Cohort 2 Arm A: Progression Free Survival (PFS) (Up to 36 Months)
• Cohort 2 Arm B: Progression Free Survival (PFS) (Up to 36 Months)

Secondary Outcomes

• Cohort 1: Baseline ctDNA (At Baseline)
• Cohort 2: Arm A and Arm B Objective Response Rate (ORR) (Up to 36 Months)
• Cohort 2: Arm A and Arm B Overall Survival (OS) (Up to 36 Months)

Full Eligibility Criteria

Inclusion Criteria:

* Be willing and able to provide written informed consent/assent.
* Must be ≥ 18 years of age on day of signing informed consent.
* Be Black / African American per self-report.
* Have an ECOG performance status of 0- 2.
* Have histologically or cytologically confirmed, advanced/metastatic NSCLC.
* Be treatment naïve in the advanced/metastatic/recurrent disease setting.
* No known EGFR/ALK/ROS1 tumor mutations. Liquid biopsies are acceptable.
* Patients who received platinum-containing adjuvant chemotherapy, neoadjuvant chemotherapy or definitive chemoradiation and/or neoadjuvant and/or adjuvant immunotherapy and/or consolidation immunotherapy therapy given for locally advanced disease and developed recurrent (local or metastatic) disease ≥ 6 months of completing therapy are eligible.
* Be planned/eligible to receive first-line therapy in the advanced/metastatic setting.
* Have testing status for PDL1 tissue status.
* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with any grade endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.
* Adequate organ function.
* Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
* Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 180 days after the last dose if treated with pembrolizumab plus chemotherapy, or 120 days after the last dose if treated with pembrolizumab monotherapy. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.
* Male subjects should agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 180 days after the last dose if treated with pembrolizumab plus chemotherapy.

Cohorts 1, 2a and b: Exclusion Criteria:

* Does not plan or is ineligible to receive pembrolizumab with or without chemotherapy per institutional standard/treating provider.
* History of allogenic tissue/solid organ transplant.

Cohort 2a and b Only: Exclusion Criteria:

* Received prior treatment chemotherapy and/or immune checkpoint inhibitor therapy in the advanced/metastatic setting for lung cancer.
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at doses

  ≥ 10 mg prednisone or any other form of systemic immunosuppressive therapy at C1D1. Subjects are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted (i.e., ≤ 10 mg/day prednisone equivalents). A brief course (≤ 7 days) of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
* Has active autoimmune disease that has required active systemic treatment in the past 2 years \[i.e., with use of disease modifying agents, corticosteroids in doses greater than 10 mg of prednisone daily (or equivalent) or immunosuppressive drugs\]. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
* Has an active infection requiring systemic therapy.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, that would substantially increase the risk of incurring adverse events (AEs) from the study medications, that would interfere with the subject's participation for the full duration of the study or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Has received a live vaccine within 30 days of planned start of study therapy.

Cohorts 1, 2a and b: Exclusion Criteria:

* Has received an investigational agent or has used an investigational device within 3 weeks prior to study intervention administration.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningit

Trial Locations

• Moffitt Cancer Center, Tampa, Florida, United States
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
• TidalHealth Peninsula Regional, Salisbury, Maryland, United States
• Montefiore Medical Cancer Center, The Bronx, New York, United States
• Baptist Clinical Research Institute, Memphis, Tennessee, United States

Frequently Asked Questions

Related Conditions

• Non-Small Cell Lung Cancer
• Lung Cancer
• Metastatic Lung Cancer
• Advanced Lung Cancer
• Cancer
• Malignant Neoplasms
• Thoracic Neoplasms
• Neoplasms
• Carcinoma, Non-Small Cell
• Adenocarcinoma

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