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Dose tapering and Early Discontinuation to InCreAse cosT-effictIveness Of immunotherapy for Non-small cell lung carcinoma trial number 1 (NVALT-30 - Dedication-1)
EU CTIS ID: 2024-516195-15-00
What this study is testing
To investigate the non-inferiority of reduced dose versus standard of care dose of pembrolizumab for treatment of advanced stage NSCLC in terms of overall survival.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal participant care.
- Participants must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
- Subjects with cytologically or histologically confirmed advanced stage or recurrent NSCLC (per the 8th International Association for the Study of Lung Cancer classification), eligible for treatment with pembrolizumab in line with ESMO guidelines.
- Known PD-L1 status (performed on cytology or histology).
- Subjects are aged ≥ 18 years.
- Women must not be breastfeeding.
You likely can't join if
- Subjects with symptomatic untreated CNS metastases are excluded. i) Subjects are eligible if CNS metastases are asymptomatic or adequately treated and neurological symptoms have returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrolment. ii) In addition, participants must be either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to treatment assignment.
- Total body weight <40 or >140 kg.
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrolment. Inhaled or topical steroids, and steroids for adrenal replacement therapy are permitted.
- A known CD4+ T-cell count of less than 100 cells/μL (CD4+ T cell count measurement is not required for patients without a history of low CD4+ T cell counts or HIV).
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Treatment with adjuvant or neoadjuvant chemotherapy 3 months prior to enrolment.
See the full eligibility criteria
Who can join
- Participants must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal participant care.
- Participants must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
- Subjects with cytologically or histologically confirmed advanced stage or recurrent NSCLC (per the 8th International Association for the Study of Lung Cancer classification), eligible for treatment with pembrolizumab in line with ESMO guidelines.
- Known PD-L1 status (performed on cytology or histology).
- Subjects are aged ≥ 18 years.
- Women must not be breastfeeding.
- Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of 5 months (30 days of ovulatory cycle plus the time required for the investigational drug to undergo five half-lives) after end of pembrolizumab treatment.
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of 7 months (90 days plus the time required for pembrolizumab to undergo five half-lives) after the last dose of investigational drug. In addition, male participants must be willing to refrain from sperm donation during this time.
What rules you out
- Subjects with symptomatic untreated CNS metastases are excluded. i) Subjects are eligible if CNS metastases are asymptomatic or adequately treated and neurological symptoms have returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrolment. ii) In addition, participants must be either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to treatment assignment.
- Total body weight <40 or >140 kg.
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrolment. Inhaled or topical steroids, and steroids for adrenal replacement therapy are permitted.
- A known CD4+ T-cell count of less than 100 cells/μL (CD4+ T cell count measurement is not required for patients without a history of low CD4+ T cell counts or HIV).
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Treatment with adjuvant or neoadjuvant chemotherapy 3 months prior to enrolment.
- Non-palliative treatment with chemoradiation for locally advanced disease 3 months prior to enrolment. Palliative radiotherapy is allowed any time.
- Women of childbearing potential (WOCBP) with a known pregnancy or a positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) prior to the start of study treatment.
- History of allergy or hypersensitivity to study drug components.
- Subjects may not have previously received a solid organ transplantation.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.