About this trial

ALK TKIs, particularly second- and third-generation ALK TKIs, have significantly improved progression-free survival (PFS) in patients with advanced ALK-positive non-small cell lung cancer (NSCLC). However, patients continue to face challenges related to drug resistance and disease progression; in the CROWN study, 40% of patients still experienced disease progression within five years. There are currently no standard treatment recommendations for this patient population. This study retrospectively evaluated the efficacy and safety of ensartinib combined with anlotinib as a second-line treatment in patients who had developed resistance to lorlatinib. The inclusion criteria for data collection were patients aged ≥18 years with histologically confirmed stage IIIB-IV ALK-positive NSCLC who had developed resistance to lorlatinib; prior to lorlatinib treatment, patients could have received up to two other ALK-TKIs, excluding ensartinib.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

Combined group of ensatinib and arotinib
Drug
Ensatinib is administered at a dose of 225 mg once daily, either on an empty stomach or with food; anlotinib is administered at a dose of 10 mg once daily, in 21-day cycles; treatment continues until disease progression, the occurrence of intolerable toxicity, withdrawal at the discretion of the investigator or the subject, loss to follow-up, initiation of other anticancer therapy, or death.

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Strict QueueOther 1 intervention

Group B: Compassionate Use CohortOther 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

If the patient has available imaging results from within 28 days prior to the first dose (bone scans may be accepted if performed within 2 months prior to the first dose), repeat imaging is not required. Tumour assessment should be performed every 6 weeks (±4 days) until tumour progression.

Time frame

After the patients were enrolled according to the inclusion criteria, the tumor assessment will be conducted every 6 weeks, and the maximum duration of the assessment is 6 months until the patients have disease progression or cannot tolerate the treatmen

Secondary outcomes

1

Secondary endpoints include progression-free survival (PFS)

Progression-free survival (PFS): defined as the time from randomisation to the first occurrence of objective tumour progression or death, whichever comes first.

Time frame

The assessment was conducted every 2 cycles (6 weeks and 24 days), and the maximum duration of the assessment was 6 months until the patient's condition progressed or could not tolerate the treatment. As of June 2028, the follow-up work has been complete

2

Overall survival (OS)

Overall survival (OS): defined as the time from randomisation to the patient's death from any cause.

Time frame

The assessment was conducted every 2 cycles (6 weeks and 24 days), and the maximum duration of the assessment was 6 months until the patient's condition progressed or could not tolerate the treatment. As of June 2028, the follow-up work has been complete

3

Duration of Response (DOR)

Duration of Response (DOR): Defined as the time from the first assessment of complete response (CR) or partial response (PR) until the first assessment of disease progression (PD) or death from any cause.

Time frame

The assessment was conducted every 2 cycles (6 weeks and 24 days), and the maximum duration of the assessment was 6 months until the patient's condition progressed or could not tolerate the treatment. As of June 2028, the follow-up work has been complete

4

Disease Control Rate (DCR)

Disease Control Rate (DCR): Defined as the proportion of patients who achieve complete response (CR), partial response (PR) or stable disease (SD) following treatment and maintain this status for a certain period.

Time frame

The assessment was conducted every 2 cycles (6 weeks and 24 days), and the maximum duration of the assessment was 6 months until the patient's condition progressed or could not tolerate the treatment. As of June 2028, the follow-up work has been complete

Locations

This trial has no locations.

Efficacy and Safety of Ensartinib Combined With Anlotinib in Lorlatinib-Resistant ALK-Positive NSCLC

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Locations

Sponsors and contacts