Pembrolizumab alone versus pembrolizumab-chemotherapy in first line NSCLC

Pembrolizumab alone versus pembrolizumab-chemotherapy in first line NSCLC - PAULIEN

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55042

Enrollment

Registered

2020-01-14

Start date

2020-02-19

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer NSCLC

Interventions

Treatment regimen (Arm 1): Sequential pembrolizumab followed by chemo at progression - Pembrolizumab monotherapy in first line • Pembrolizumab monotherapy 3 or 6-weekly until progression at fixed dos

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Histologically confirmed NSCLC, negative for EGFR and ALK mutations • WHO PS 0-2 • No prior systemic therapy • High PD-L-1 expression (>=50% TPS) • High tumor burden (metastases (M1)) and not amenable for local consolidative therapies

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Patients amenable for local consolidative therapies • Use of steroids equivalent to >10 mg prednisolon per day prior to start of study • Untreated brain metastases • Adequate bone marrow and organ functions (renal and liver) • Uncontrolled active infections, HIV • Autoimmune diseases and interstitial lung diseases are to be excluded depending on physicians decision

Design outcomes

Primary

Measure	Time frame
1. ORR, as defined by partial response (PR) and complete response (CR) at week 6 2. Disease control rate (DCR), as defined by stable disease (SD) and PR and CR at week 6	—

Secondary

Measure	Time frame
1. PFS, as determined using Response Evaluation Criteria in Solid Tumors (RECIST1.1) and defined as time to the development of new lesions, progression of existing lesions, or death, whichever comes first. 2. PFS-2, as defined by the PFS on second line chemotherapy in arm 1. 3. ORR-2, as defined by the ORR on second line chemotherapy in arm 1. 4. Overall Survival (OS). Time frame: Baseline until death. 5. Safety defined as the percentage of patients with adverse events. Adverse events will be defined as described in the Common Terminology Criteria for Adverse Events (CTCAE).	—

Measure

Time frame

1. PFS, as determined using Response Evaluation Criteria in Solid Tumors (RECIST1.1) and defined as time to the development of new lesions, progression of existing lesions, or death, whichever comes first. 2. PFS-2, as defined by the PFS on second line chemotherapy in arm 1. 3. ORR-2, as defined by the ORR on second line chemotherapy in arm 1. 4. Overall Survival (OS). Time frame: Baseline until death. 5. Safety defined as the percentage of patients with adverse events. Adverse events will be defined as described in the Common Terminology Criteria for Adverse Events (CTCAE).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)