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Outcome Measures

Primary Outcomes (1)

Number of Participants With Dose-Limiting Toxicity (DLT) Events as Assessed by CTCAE v4.03
Modified 3+3 dose escalation design will be used to determine whether the addition of idelalisib to standard pembrolizumab is safe and tolerable in checkpoint inhibitor refractory NSCLC patients. An initial cohort of 3 patients will receive 50 mg twice daily idelalisib with standard pembrolizumab. If none of the 3 patients develop a DLT, another 3 patients will be enrolled. Dose will be escalated or de-escalated based on the occurrence of DLTs. All events will be assessed for possible, probable, or definite relation to idelalisib.
First 9 weeks at each dose level

Secondary Outcomes (2)

Dose-Finding Assessment for Optimum Dose of Idelalisib in Combination With Pembrolizumab
18-27 weeks
Overall Response Rates (ORR) to Combination Therapy
18 weeks - 2 years

Study Arms (2)

Phase 1 Dose Escalation

EXPERIMENTAL

Sequential cohorts of 3 patients will receive pembrolizumab 200 mg intravenously every 3 weeks, in addition to the oral drug, idelalisib, every day for 21 days. The first group of 3 will receive idelalisib 50 mg twice daily; the next cohort will receive idelalisib 100 mg twice daily; the last cohort will receive idelalisib 150 mg twice daily.

Drug: PembrolizumabDrug: Idelalisib

Phase 2 Efficacy

EXPERIMENTAL

All patients in the efficacy assessment phase will be treated with pembrolizumab (200 mg intravenously every 3 weeks) in combination with oral idelalisib (dose not exceeding 150 mg twice daily, per the phase 1 assessment) for 18 weeks before maintenance with pembrolizumab 200 mg intravenously every 3 weeks for up to 2 years, until disease progression or unacceptable toxicity.

Drug: PembrolizumabDrug: Idelalisib

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungNeoplasm MetastasisRecurrence

Interventions

pembrolizumabidelalisib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type

interventional

Phase

phase 1 2

Allocation

NON RANDOMIZED

Masking

NONE

Purpose

TREATMENT

Intervention Model

SEQUENTIAL

Model Details: This is an open labeled, single arm, interventional study combining standard pembrolizumab (MK-3475, trade name: Keytruda) with investigational agent, idelalisib (trade name: Zydelig) in non-small cell lung cancer (NSCLC). The study will enroll patients in two phases: a dose finding/tolerability assessment phase and an efficacy assessment phase. The Phase 1b (modified 3+3 dose escalation) assessment will determine the safe dose of idelalisib in combination with pembrolizumab that down-regulates the activity of T-regulatory function (Treg). The Phase 2 efficacy assessment will enroll patients to detect whether idelalisib added to pembrolizumab at the phase 2 recommended dose (P2RD) will result in further objective response.

Sponsor Type

OTHER

Responsible Party

SPONSOR INVESTIGATOR

PI Title

Professor of Medicine

Study Stopped

Pembrolizumab + Idelalisib for Lung Cancer Study

Brief Summary

Registry Overview

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First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Phase 1 Dose Escalation

Phase 2 Efficacy

Interventions

Eligibility Criteria

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Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

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Results Point of Contact

Study Officials

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Study Record Dates

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Data Sharing

Source record

Documents

Locations

Study Stopped

Pembrolizumab + Idelalisib for Lung Cancer Study

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Phase 1 Dose Escalation

Phase 2 Efficacy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations