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Non-interventive registration study on the treatment of advanced non-small cell lung cancer patients who had previously failed to receive PD-1/PD-L1 inhibitors with Anlotinib hydrochloride and PD-1/PD-L1 inhibitors

Non-interventive registration study on the treatment of advanced non-small cell lung cancer patients who had previously failed to receive PD-1/PD-L1 inhibitors with Anlotinib hydrochloride and PD-1/PD-L1 inhibitors

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300069510
Enrollment
Unknown
Registered
2023-03-20
Start date
2023-03-20
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC

Interventions

Advanced non small cell lung cancer patients who failed first-line treatment with PD-1/PD-L1 inhibitors:Non-intervention

Sponsors

Lankao County First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) , male or female patients aged 18-75; (2)?ECOG PS 0-1; (3) , patients with locally advanced and/or metastatic stage IIIB, IIIC or IV (according to the 8th edition of the United States Joint Commission on Cancer Lung Cancer Staging System) NSCLC who have previously failed to receive first-line PD-1/PD-L1 inhibitor treatment, confirmed by histology or cytology and cannot undergo radical synchronous radiotherapy and chemotherapy. ? Definition of treatment failure: a Proven disease progression occurred during the treatment of PD-1/PD-L1 inhibitor or after the last treatment; B. Withdrawal due to intolerance of adverse events or unwillingness to continue treatment; C. For subjects who have previously received PD-1/PD-L1 inhibitor synchronous or sequential chemotherapy, synchronous or sequential radiochemotherapy, if relapse/metastasis occurs within 6 months after the last treatment, the original treatment plan is defined as the first-line treatment plan for the subject. (4) All patients should be EGFR/ALK/ROS1 wild type; (5) There is at least one target lesion that has not received radiotherapy in the past six months, and can be accurately measured in at least one direction by magnetic resonance imaging (MRI) or computed tomography (CT), with its maximum diameter = 10 mm;

Exclusion criteria

Exclusion criteria: (1) . Patients who have previously used anlotinib hydrochloride capsules or other anti-angiogenic drugs, or who have been judged by the researcher to be unsuitable for the use of anti-angiogenic drugs. (2) , patients with anltinib and contraindications to immunotherapy. (3) . Patients whose adverse reactions (excluding hair loss) related to anti-tumor treatment after previous systemic anti-tumor treatment have not recovered to NCI-CTCAE = 1;

Design outcomes

Primary

MeasureTime frame
Disease remission rate;

Secondary

MeasureTime frame
Progression-free survival;Total lifetime;Disease control rate;Safety index;

Countries

China

Contacts

Public ContactjianguoDong

Lankao First Hospital

1246739720@qq.com13937805688

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026