Non-Small Cell Lung CancerPhase 2NCT06731413
Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Reduced Dose of Chemotherapy and Immunotherapy in people with Non-Small Cell Lung Cancer and NSCLC, run by Virginia Commonwealth University at 2 sites in United States.
Trial summary
Evaluate frequency of adverse events that lead to chemotherapy discontinuation in vulnerable older adults with recurrent/metastatic PD-L1 TPS<50% NSCLC patients who receive reduced dose chemotherapy in combination with immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, NSCLC, Advanced Non-Small Cell Lung Cancer
- What is being tested?
- Reduced Dose of Chemotherapy and Immunotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Feb 2025to 30 Jul 2033
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) (either squamous or non- squamous)
- Stage IIIB, IIIC or IV disease OR have recurrent disease and not be candidates for curative treatment such as combined chemo-radiation
- No previous line of treatment in the recurrent or metastatic setting. Neoadjuvant or adjuvant treatment more than 6 months before enrollment is acceptable.
- Age 70 or meeting frailty definition or above at the date of signing informed consent
- Absence of driver mutations that have first line Food and Drug Administration (FDA) approved targeted therapy (biomarker testing is optional for squamous cell)
- PD-L1 tumor proportion score (TPS) of less than 50%
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- Eastern Cooperative Oncology Group (ECOG) PS of 0-3
- Have measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment
- Absolute neutrophil count (ANC) ≥ 1,000/μL
- Platelets ≥ 75,000/μL
- Hemoglobin (Hgb) ≥ 8.0 g/dL (transfusion permitted)
- Total bilirubin ≤ 2 x institutional upper limit of normal (ULN)
- Aspartate amino transferase (AST)serum glutamic-oxaloacetic transaminase (SGOT) /alanine aminotransferase (ALT)serum glutamic-pyruvic transaminase (SGPT) ≤ 5.0 × institutional ULN
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Participants with life expectancy of less than 3 months at the time of enrollment
- Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, or immunosuppressive drugs)
- Diagnosis of interstitial lung disease
- Creatinine clearance of <30 mL/min
- Symptomatic, untreated central nervous system (CNS) disease or leptomeningeal disease. Patients with asymptomatic or treated CNS disease are eligible
- Required ongoing use of immunosuppressive medication, including steroids, with the following allowable exceptions:
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- Doses less than or equal to the equivalent of prednisone 10 mg daily
- Short courses of steroids that are discontinued prior to enrollment
- Inhaled, intranasal and/or topical steroids
- Dexamethasone taper for treating vasogenic edema associated with CNS disease
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Massey Lung Team, 804-628-6430, masseylung@vcu.edu
Jonathan Berkman, MD
- Recruiting
VCU Health Tappahannock Hospital
Tappahannock, Virginia, 22560
Massey CTO Lung Team, 804-628-6430, masseylung@vcu.edu
Jonathan Berkman, MD
About this study
Official title: Phase 2 Study to Evaluate Reduced Dose Chemotherapy in Combination With Anti-PD-1 Therapy as First Line Treatment in Vulnerable or Older Adults (Vulnerable or Age ≥70) With Advanced PD-L1 TPS <50% Non-small Cell Lung Cancer
Evaluate frequency of adverse events that lead to chemotherapy discontinuation in vulnerable older adults with recurrent/metastatic PD-L1 TPS<50% NSCLC patients who receive reduced dose chemotherapy in combination with immunotherapy.
Read the detailed description
This is a single institution, single arm, open label phase 2 study in vulnerable or older adults (Age ≥70) with recurrent or metastatic, histologically confirmed squamous cell carcinoma or non-squamous cell carcinoma of lung without driver mutation and PD-L1 TPS < 50% to evaluate safety and tolerability of reduced dose of chemotherapy and immunotherapy.
- Conditions
- Non-Small Cell Lung Cancer, NSCLC, Advanced Non-Small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer
- Being tested
- Reduced Dose of Chemotherapy and Immunotherapy
- Keywords
- Non-Small Cell Lung Cancer, NSCLC
- 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.
Reduced Dose of Chemotherapy and ImmunotherapyDrug
Eligible participants with recurrent or metastatic squamous cell carcinoma will receive 4 cycles of carboplatin area under the curve (AUC) 3 IV every 21 days and paclitaxel 135 mg/m2 intravenous (IV) every 21 days. Participants with non-squamous histology will receive carboplatin AUC 3 IV every 21 days and pemetrexed 375 mg/m2 IV every 21 days (collectively, induction chemotherapy). Both groups will receive pembrolizumab 200 mg IV every 21 days for a total of up to 35 cycles (Cycles ≥5 are collectively the maintenance portion of treatment) or until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Reduced Dose Combination Therapy | Experimental | Squamous cell histology:
1. Carboplatin AUC 3 every 21 days IV for 4 cycles
2. Paclitaxel 135 mg/m2 every 21 IV days for 4 cycles
3. Pembrolizumab 200 mg every 21 days IV until disease progression or unacceptable toxicity up to 35 cycles
Non-squamous histology:
1. Carboplatin AUC 3 every 21 days IV for 4 cycles
2. Pemetrexed 375 mg/m2 every 21 IV days for 4 cycles
3. Pembrolizumab 200 mg every 21 days IV until disease progression or unacceptable toxicity up to 35 cycles Receives: Drug: Reduced Dose of Chemotherapy and Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of chemotherapy discontinuation due to treatment-related adverse events
Evaluate treatment tolerability i by the number of participants that discontinue chemotherapy treatment due to treatment-related adverse events.
Measured: Through completion of protocol therapy, up to 2 years
Secondary outcomes (5)
Response (complete response and partial response) per Response Evaluation Criteria in Solid Tumors
Evaluate overall response defined by complete and partial response in vulnerable or older adults with recurrent/metastatic PD-L1 TPS <50% NSCLC patients who receive reduced dose chemotherapy in combination with immunotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Measured: Up to 5 years
Overall incidence and severity of all adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
The total number of AE's recorded for the protocol.
Measured: Time of patient consent and throughout the duration of the study, including during the treatment period and for 30 days following the final dose of the study medication, up to 2 years and 1 month
Overall survival defined as the time from the date of first study treatment until the date of death. Overall survival (OS) will be censored on the last date a participant was known to be alive
Overall survival of participants measured in days.
Measured: Up to 5 years
Progression-free survival (PFS) measured from the date of first study treatment until the date of documented disease progression
Evaluate progression-free survival of participants in days utilizing RECIST 1.1 criteria or death from any cause, whichever occurs first.
Measured: Up to 5 years
Cancer related symptoms and quality of life
Evaluate impact of the reduced dose combination therapy on quality of life as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ C30). The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients.The functioning and the global QoL scales, a higher score indicates better health. Response options are on a 4-point Likert-type scale (not at all; a little; quite a bit; very much) and a 7-point Likert scale for global HRQoL ranging from 'Very poor' to 'Excellent'. The QLQ-C30 summary score is calculated as the mean of the combined 13 QLQ-C30 scale and item scores with a higher score indicating a better HRQoL.
Measured: Baseline, Cycle 3 Day 1, Cycle 5 Day 1 Cycle 9 Day 1, EOT Visit (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start11 Feb 2025
- Primary completion30 Jul 2030 (estimated)
- Study completion30 Jul 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.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Berkman, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731413
- Sponsor's protocol ID
- MCC-24-21788
- Status last verified
- May 2026
- First submitted
- 6 Dec 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Currently there are no plans to share IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study to Evaluate Reduced Dose Chemotherapy in Combination With Anti-PD-1 Therapy as First Line Treatment in Vulnerable or Older Adults (Vulnerable or Age ≥70) With Advanced PD-L1 TPS <50% Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06731413
- Acronym / sponsor ID
- MCC-24-21788
- Conditions
- Non-Small Cell Lung Cancer, NSCLC, Advanced Non-Small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 30 Jul 2030 (estimated)
- Study completion
- 30 Jul 2033 (estimated)
- First posted
- 12 Dec 2024 (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.
Evaluate frequency of adverse events that lead to chemotherapy discontinuation in vulnerable older adults with recurrent/metastatic PD-L1 TPS<50% NSCLC patients who receive reduced dose chemotherapy in combination with immunotherapy.
Detailed description
This is a single institution, single arm, open label phase 2 study in vulnerable or older adults (Age ≥70) with recurrent or metastatic, histologically confirmed squamous cell carcinoma or non-squamous cell carcinoma of lung without driver mutation and PD-L1 TPS < 50% to evaluate safety and tolerability of reduced dose of chemotherapy and immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reduced Dose Combination Therapy | Experimental | Drug: Reduced Dose of Chemotherapy and ImmunotherapySquamous cell histology: 1. Carboplatin AUC 3 every 21 days IV for 4 cycles 2. Paclitaxel 135 mg/m2 every 21 IV days for 4 cycles 3. Pembrolizumab 200 mg every 21 days IV until disease progression or unacceptable toxicity up to 35 cycles Non-squamous histology: 1. Carboplatin AUC 3 every 21 days IV for 4 cycles 2. Pemetrexed 375 mg/m2 every 21 IV days for 4 cycles 3. Pembrolizumab 200 mg every 21 days IV until disease progression or unacceptable toxicity up to 35 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) (either squamous or non- squamous)
- Stage IIIB, IIIC or IV disease OR have recurrent disease and not be candidates for curative treatment such as combined chemo-radiation
- No previous line of treatment in the recurrent or metastatic setting. Neoadjuvant or adjuvant treatment more than 6 months before enrollment is acceptable.
- Age 70 or meeting frailty definition or above at the date of signing informed consent
- Absence of driver mutations that have first line Food and Drug Administration (FDA) approved targeted therapy (biomarker testing is optional for squamous cell)
Key exclusion criteria (10 listed)
- Participants with life expectancy of less than 3 months at the time of enrollment
- Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, or immunosuppressive drugs)
- Diagnosis of interstitial lung disease
- Creatinine clearance of <30 mL/min
- Symptomatic, untreated central nervous system (CNS) disease or leptomeningeal disease. Patients with asymptomatic or treated CNS disease are eligible
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 |
|---|---|---|
| Reduced Dose of Chemotherapy and ImmunotherapyEligible participants with recurrent or metastatic squamous cell carcinoma will receive 4 cycles of carboplatin area under the curve (AUC) 3 IV every 21 days and paclitaxel 135 mg/m2 intravenous (IV) every 21 days. Participants with non-squamous histology will receive carboplatin AUC 3 IV every 21 days and pemetrexed 375 mg/m2 IV every 21 days (collectively, induction chemotherapy). Both groups will receive pembrolizumab 200 mg IV every 21 days for a total of up to 35 cycles (Cycles ≥5 are collectively the maintenance portion of treatment) or until disease progression or unacceptable toxicity. | Drug | Reduced Dose Combination Therapy |
Primary outcome
Occurrence of chemotherapy discontinuation due to treatment-related adverse events
Time frame: Through completion of protocol therapy, up to 2 years
Evaluate treatment tolerability i by the number of participants that discontinue chemotherapy treatment due to treatment-related adverse events.
5 secondary outcomes
Response (complete response and partial response) per Response Evaluation Criteria in Solid Tumors
Time frame: Up to 5 years
Overall incidence and severity of all adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time frame: Time of patient consent and throughout the duration of the study, including during the treatment period and for 30 days following the final dose of the study medication, up to 2 years and 1 month
Overall survival defined as the time from the date of first study treatment until the date of death. Overall survival (OS) will be censored on the last date a participant was known to be alive
Time frame: Up to 5 years
Progression-free survival (PFS) measured from the date of first study treatment until the date of documented disease progression
Time frame: Up to 5 years
Cancer related symptoms and quality of life
Time frame: Baseline, Cycle 3 Day 1, Cycle 5 Day 1 Cycle 9 Day 1, EOT Visit (up to 2 years)
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 2 Jun 2026.
- Individual participant dataSharing planned: No. Currently there are no plans to share IPD with other researchers.
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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.
Jonathan Berkman, MD principal investigator
Virginia Commonwealth University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Reduced Dose of Chemotherapy and Immunotherapy in people with Non-Small Cell Lung Cancer and NSCLC, run by Virginia Commonwealth University at 2 sites in United States.
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 14 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Massey IIT Research Operations (804-628-6430, masseyepd@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of chemotherapy discontinuation due to treatment-related adverse events (time frame: Through completion of protocol therapy, up to 2 years). 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 2 Jun 2026.