REZILIENT4

13 evidence topics · 3 sources

Objective

Adjuvant treatment objective

“stop cancer from coming back” (opens the source at this quote in a new tab)

Location and study date

UK research ethics opinion date

“13 Nov 2025” (opens the source at this quote in a new tab)

Study design

Adjuvant development phase

“Phase 3” (opens the source at this quote in a new tab)

Randomization, masking, and multicenter design

“Randomized, Placebo-Controlled, Double-Blind, Multi-Center” (opens the source at this quote in a new tab)

Eligibility criteria

Adjuvant disease population

“Pathologic (post-operative) Stage IB, IIA, IIB, or IIIA according to the AJCC 9th tumor nodes metastasis (TNM) staging system for lung cancer.” (opens the source at this quote in a new tab)

Minimum enrollment age, years

“About 360 people who are at least 18 years old can enroll in this study.” (opens the source at this quote in a new tab)

Treatment

Adjuvant randomized comparison

“Arm A: Zipalertinib twice daily (BID) monotherapy OR Arm B: Placebo BID monotherapy.” (opens the source at this quote in a new tab)

Study-drug dose

“All participants will receive either 100 milligrams of zipalertinib or placebo, orally as tablets, along with other cancer drugs, twice a day in a 21-day cycle.” (opens the source at this quote in a new tab)

Study-drug dosing frequency

“twice a day” (opens the source at this quote in a new tab)

Maximum total study-drug treatment duration

“3 years” (opens the source at this quote in a new tab)

Study outcomes

Rationale for using disease-free survival as the primary endpoint

Regulatory setting for disease-free survival endpoints

“the adjuvant setting after definitive surgery or radiotherapy.” (opens the source at this quote in a new tab)

Statistical analysis description

Number of participants (Planned and analyzed)

Planned enrollment, participants

“360” (opens the source at this quote in a new tab)

Description of analysis sets

No evidence found.

Results

Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results

No evidence found.

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

No evidence found.

Study limitations

Summary

The report contains trial-design information, not results. Eligibility covers uncommon EGFR mutations rather than exon 20 insertions alone, and the planned enrollment is 360 participants. No efficacy or safety estimate can be drawn from these protocol details.