NSCLC: EXCLAIM trial

Abbreviations

No EU-CTR

  • EXCLAIM references
    2022-02-24
    Caicun Zhou
    Treatment Outcomes and Safety of Mobocertinib in Platinum-Pretreated Patients With EGFR Exon 20 Insertion–PositiveMetastatic NSCLC
Investigated (inv)
Comparator (comp)

MOBO

na

210

na

Phase:

2

Randomisation:

Open label

Primary tumour:

NSCLC

Subtype (biomarker):

EGFR ex20ins MT

Stage:

meta

Line of therapy:

L3

Primary
MOBO
na
HR
p
ORR IRC
25%
Secondaries
MOBO
na
HR
p
ORR inv.
32%
na
na
na
DoR IRC
NR
na
na
na
PFS IRC
7.3 mo.
na
na
na
OS
NR
na
na
na
(all grades, %)
MOBO
na
p
Diarrhea
93%
NA
Rash—
45%
NA
Paronychia
39%
NA
Nausea
30%
NA
Vomiting
26%
NA
Blood creatinine increased
28%
NA
Lipase increased
17%
NA
Amylase increased
20%
NA
Anemia
19%
NA
Electrocardiogram QT prolonged
8%
NA
  • Inclusion
  • Exclusion

General Inclusion Criteria all cohorts: dose escalation, antidiarrhea prophylaxis, dose escalation combination, expansion, and extension: Have histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) or metastatic NSCLC disease (Stage IIIB or IV) or other solid tumors. For all cohorts except Expansion Cohort 7, the locally advanced or metastatic disease is NSCLC. For Expansion Cohort 7, the locally advanced or metastatic disease is any solid tumor other than NSCLC. Must have sufficient tumor tissue available for analysis. Must have measurable disease by response evaluation criteria in solid tumors (RECIST) v1.1. Male or female adult participants (aged 18 years or older, or as defined per local regulations). Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. Minimum life expectancy of 3 months or more. Adequate organ function at baseline. Normal QT interval on screening el

Previously received TAK-788. Received small-molecule anticancer therapy (including cytotoxic chemotherapy, and investigational agents, ≤ 14 days prior to first dose of TAK-788 (except for reversible EGFR TKIs [that is, erlotinib or gefitinib], which are allowed in the dose escalation and expansion cohorts up to 7 days prior to the first dose of TAK-788). Received antineoplastic monoclonal antibodies including immunotherapy within 28 days of the first dose of TAK-788. Have been diagnosed with another primary malignancy other than NSCLC except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or participants with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy. Note: This exclusion criteria does not apply to Expansion Cohort 7. Received radiotherapy <=14 days prior to the first dose o

Characteristics
MOBO
na
Agedc-comma sex
Median age (range) yr
59 (27-80)
Male - no.(%)
34 (35)
Female - no.(%)
62 (65)
Race - no.(%)
Asian
66 (69)
Black or African American
2 (2)
White
28 (29)
Not reported
0
Ethnicity - no.(%)
Hispanic or Latino
95 (99)
Not Hispanic or Latino
1 (1)
Histologic type - no.(%)
Adenocarcinoma
95 (99)
Squamous
1 (1)
Large cell
0
ECOG performance status - no.(%)
0
28 (29)
1
68 (71)
History of smoking - no.(%)
Never
70 (73)
Former
24 (25)
Current
2 (2)
No. of prior systemic anticancer regimens - no.(%)
1
49 (51)
2
30 (31)
≥3
17 (18)
Prior systemic anticancer therap
Platinum-based chemotherapy
86 (90)
Immunotherapy
33 (34)
EGFR TKI
30 (31)
Baseline brain metastases - no.(
Baseline brain metastases
33 (34)
Ad-hoc:
no.pts inv.
no.pts comp.
MOBO
na
HR
p
DoR inv.
11.2 mo
PFS inv.
7.3 mo
  • ORR IRC
analisys of ORR IRC
MOBO
na
HR (95% CI)
analisys of
MOBO
na
HR (95% CI)