CLN-081 for Non-Small Cell Lung Cancer

Q: How many locations are deploying this experiment?

<p>12 facilities are participating in the trial, <a href="https://www.withpower.com/clinical-trials/ra">ra</a>nging from University of California Davis Comprehensive Cancer Center in Sacramento to Massachusetts General Hospital in Boston and Pacific Shores Medical Group in Long Beach.</p>

Phase-Based Progress Estimates

Effectiveness

Safety

Sun Yat Sen University Cancer Center, Guangzhou, ChinaNon-Small Cell Lung Cancer+1 MoreCLN-081 - Drug

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Eligibility

18+

All Sexes

What conditions do you have?

Select

Eligibility

18+

All Sexes

What conditions do you have?

Select

Study Summary

This trial is testing a new drug for patients with a specific type of lung cancer. The goal is to find the best dose of the drug and to see if it is effective.

Eligible Conditions

Non-Small Cell Lung Cancer
EGFR Gene Mutation Exon 20

Treatment Effectiveness

Effectiveness Progress

1 of 3

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SQ3370

Furmonertinib

Study Objectives

8 Primary · 10 Secondary · Reporting Duration: 24 months

24 months

All Cohorts: Assessment of area under curve (AUC)

All Cohorts: Assessment of maximum concentration (Cmax)

All Cohorts: Assessment of mean residence time (MRT)

All Cohorts: Assessment of terminal half-life (t1/2)

All Cohorts: Assessment of time to maximum concentration (tmax)

All Cohorts: Incidence of abnormalities in vital signs.

All Cohorts: Incidence of safety laboratory assessment abnormalities.

All Cohorts: The rate and severity of DLTs.

All Cohorts: The rate and severity of treatment emergent AEs.

Module A: Pharmacokinetic (PK) parameter

Module B: Confirmed overall response rate (ORR) by independent review committee (IRC)

Phase 1 Dose Escalation and Dose Expansion Cohorts: DCR (disease control rate)

Phase 1 Dose Escalation and Dose Expansion Cohorts: DOR (duration of response).

Phase 1 Dose Escalation and Dose Expansion Cohorts: ORR

Phase 1 Dose Escalation and Dose Expansion Cohorts: OS (overall survival)

Phase 1 Dose Escalation and Dose Expansion Cohorts: PFS (progression free survival)

Heart rate

Phase 2a Dose Expansion Cohorts: Overall response rate (ORR)

Trial Safety

Safety Progress

1 of 3

Similar Trials

HMPL-306

SQ3370

Furmonertinib

Trial Design

8 Treatment Groups

Module B

1 of 8

Module B- Part 1/ Part 2

1 of 8

Module A Food Affect

1 of 8

Module C

1 of 8

Phase 1 Dose Expansion(s)

1 of 8

Phase 1 Dose Escalation (Accelerated Titration)

1 of 8

Phase 1 Dose Escalation (Rolling Six)

1 of 8

Phase 2a Dose Expansion(s)

1 of 8

Experimental Treatment

284 Total Participants · 8 Treatment Groups

Primary Treatment: CLN-081 · No Placebo Group · Phase 1 & 2

Module B

Drug