Third-generation EGFR-TKI Plus Anlotinib as Maintenance for NSCLC With Small Cell Transformation After EGFR-TKI Resistance

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHunan Province Tumor Hospital

About this trial

This study aimed to evaluate the efficacy and safety of third-generation EGFR-TKI plus anlotinib as maintenance after chemotherapy plus immunotherapy in advanced NSCLC with small cell transformation after EGFR-TKI resistance.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.

2. Age ≥ 18 years.

3. Histopathology is confirmed non-small cell lung cancer .

4.Patients with advanced non-small cell lung cancer (NSCLC) who experienced small cell transformation after EGFR-TKI resistance.

Disqualifiers

1. History of other malignant tumors within 2 years.

2. Adverse events (except alopecia of any degree) of CTCAE > grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.

3. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.

4. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.

Trial design

Design model

Single group

Treatments tested in this trial

  • third-generation EGFR-TKI combined with anlotinib

    Drug

    third-generation EGFR-TKI combined with anlotinib as maintenance therapy following 4 to 6 cycles of chemotherapy and immunotherapy until progressive disease.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: The experimental cohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

progression-free survival (PFS)

PFS was defined as the duration from the start of standard chemotherapy plus immunotherapy to disease progression or last follow up

Time frame
Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month

Secondary outcomes

1

Objective Response Rate (ORR)

To assess overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)

Time frame
Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month
2

Adverse events (AEs) according to CTCAE 5.0

Number of participants with adverse events (AEs) according to CTCAE 5.0

Time frame
Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: