TROPION-Lung01 Study Design and Baseline demographics
Patient Characteristics and Disposition
Demographic characteristics
Relative Frequency of Genomic Alterationsb-d
Daiichi-Sankyo
Median age (range), years
Female, n (%)
Histology, n (%)
Adenocarcinoma
History of brain metastasis, n (%) a
Median prior lines of therapy for adv/met disease
Prior lines of therapy, n (%)
≥3 prior lines of therapy for adv/met disease
Prior platinum chemotherapy
Prior anti-PD-1/anti-PD-L1 immunotherapy
≥2 prior lines of targeted therapies for indicated
genomic alteration
Dato-DXd
(N=137)
60 (29-79)
83 (61)
ALK
rearrangement
25%
130 (95)
EGFR
mutatione
57%
70 (51)
3
137 (100)
98 (72)
137 (100)
49 (36)
82 (60)
Disposition
ROS1 rearrangement
7%
RET rearrangement
6%
MET exon 14 skipping
BRAF mutation 4%
3%
At the time of data cutoff (December 14, 2022):
Median (range) treatment duration was 4 (1-21) months
60 participants (44%) were ongoing in study
20 participants (15%) were ongoing on study treatment
adv/met, advanced/metastatic, Dato-DXd, datopotamab deruxtecan; PD-1, programmed cell death 1 protein; PD-L1, programmed cell death 1 ligand 1.
*Patients with clinically inactive brain metastases and patients with treated brain metastases who are no longer symptomatic, require no treatment with corticosteroids or anticonvulsants, and have recovered from radiotherapy may be included in the
study. *Patients whose tumors harbor KRAS mutations, in the absence of the genomic alterations EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, and RET, were excluded from the study. Three patients had tumors with MET amplification.
*Patients had co-occurring alteration types; thus, percentages do not sum to 100%. *Protocol requires enrollment of 50% of patients with EGFR-mutated tumors, among whom 80% should have received prior osimertinib.
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