TROPION-Lung05

11 evidence topics · 2 sources

Objective

Molecularly selected study population

“actionable genomic alterations” (opens the source at this quote in a new tab)

Location and study date

Snapshot data cutoff

“The data cutoff date for the primary analysis (ie, when all patients had ≥9 months of follow-up after treatment initiation or had discontinued from the study, whichever occurred first) was December 14, 2022.” (opens the source at this quote in a new tab)

Study design

Trial phase

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

Eligibility criteria

Required previous treatment classes

“targeted therapy” (opens the source at this quote in a new tab)
“platinum-based chemotherapy” (opens the source at this quote in a new tab)

Treatment

Datopotamab deruxtecan dose

“6 mg/kg” (opens the source at this quote in a new tab)

Study outcomes

Rationale for using objective response rate as the primary endpoint

Primary outcome

“objective response rate” (opens the source at this quote in a new tab)

Statistical analysis description

Number of participants (Planned and analyzed)

Treated participants

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

Description of analysis sets

Results

Participant disposition

Baseline characteristics

Genomic alteration groups

EGFR-mutated	ALK-rearranged
“56.9%”	“24.8%”

Efficacy results

Objective response rate

Overall study population	EGFR-mutated subgroup
“35.8%”	“43.6%”

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

Study-wide safety outcomes

Safety outcome	Quoted percentage
Grade 3 or higher treatment-related adverse events	“28.5%”
Adjudicated treatment-related interstitial lung disease or pneumonitis	“3.6%”
Grade 5 interstitial lung disease or pneumonitis	“0.7%”

Study limitations

Summary

The 137-participant population included multiple genomic subgroups; 56.9% had EGFR mutations. The overall ORR and safety percentages should not be presented as EGFR-specific estimates. The EGFR-subgroup ORR of 43.6% is not a randomized comparison with ivonescimab.