A Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2

ConditionExtensive Stage Lung Small Cell Cancer

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorETOP IBCSG Partners Foundation

About this trial

START-lung is an international, multicentre, single-arm phase II trial. Protocol treatment consists of tarlatamab administered as an intravenous infusion until disease progression according to RECIST v1.1 criteria, unacceptable toxicity, or patient decision, whichever comes first. The primary objective of the trial is to assess the clinical efficacy of tarlatamab, in terms of 12-month OS rate, in patients with ES-SCLC and ECOG PS 2 who have previously received only one line of platinum-etoposide doublet chemotherapy with immune-checkpoint inhibition and whose disease has progressed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed ES-SCLC.

Previous treatment with only one line of platinum-etoposide doublet chemotherapy with immune-checkpoint inhibition for SCLC.

Progressive disease on or after the first-line treatment for SCLC.

ECOG Performance Status 2.

Disqualifiers

Symptomatic CNS metastases Patients with untreated asymptomatic brain metastases and patients with treated and stable brain metastases are eligible.

Diagnosis or evidence of leptomeningeal disease or spinal cord compression

any severe or life-threatening immune-mediated adverse event,

history of immune-mediated encephalitis or another immune-mediated CNS event (any grade),

Trial design

Design model

Single group

Treatments tested in this trial

Tarlatamab
Drug
Protocol treatment consists of tarlatamab, administered as an intravenous (i.v.) infusion: * 1 mg on day 1 (C1D1), * 10 mg on day 8 (C1D8) and * 10 mg on day 15 (C1D15), * then 10 mg every two weeks (Q2W) until disease progression according to RECIST v1.1 criteria, unacceptable toxicity, or patient decision, whichever comes first.

Treatment groups

48 Participants

are divided into 1 treatment group

Group A: TarlatamabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Overall survival rate at 12 months (12-month OS)

The OS rate at 12 months is the primary endpoint of the trial. It is defined as the proportion of patients who are alive at 12 months from enrolment. The rate will be calculated as the number of patients alive at 12 months divided by the number of patients on follow-up at 12 months or with an earlier observed death event.

Time frame

OS is defined as the time from the date of enrolment until death from any cause. Assessed for approximately up to 41 months.

Secondary outcomes

Objective response rate (ORR)

Objective response rate (ORR) is defined as the rate of patients, among all those enrolled, who achieve a best overall response \[complete response (CR) or partial response (PR)\] according to the RECIST v1.1 across all post-enrolment time-points until the end of follow up for disease progression.

Time frame

Assessed for approximately up to 41 months.

Duration of response (DoR)

Duration of response (DoR) is defined as the time from the date of first documentation of objective response (CR or PR according to RECIST v1.1) to the date of first documented progression or death. Censoring will occur at the last tumour assessment with response other than progression. Patients without tumour assessment after documented objective response will be censored at the date of documented objective response (plus 1 day).

Time frame

Assessed for approximately up to 41 months.

Disease control rate (DCR)

Disease control rate (DCR) is defined as the rate of patients, among all those enrolled, who achieve CR or PR according to RECIST v1.1 or stabilisation of disease (SD), lasting for at least 12 weeks.

Time frame

Assessed for approximately up to 41 months.

Progression-free survival (PFS)

Progression-free survival (PFS) is defined as the time from the date of enrolment until documented progression (according to RECIST v1.1) or death if progression is not documented. Censoring (for patients without documented progression or death) will occur at the date of last tumour assessment. Patients without a post-baseline tumour assessment will be censored at the date of enrolment (plus 1 day).

Time frame

Assessed for approximately up to 41 months.