Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer (CREATE)

Hunan Province Tumor Hospital

Status: Enrolling

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Immune checkpoint inhibitor

Study type: Observational

Funder types: Other

Identifiers

NCT05059951

20210113 (Other Identifier)

Details and patient eligibility

About

Although several clinical trials provide evidence for efficacy benefit for Checkpoint Inhibitors plus chemotherapy for lung cancer. However, there was rare evidence for clinical evidence in Hunan province.

Full description

This prospective study aimed to assess its efficacy and adverse event for Checkpoint Inhibitors with or without chemotherapy in clincial practice. Several cohorts were devided including pathological type, treatment line, treatment regiems, combination strategies. Tissue samples were collected with permission of patients for TME evaluation.

Enrollment: 15,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥18，Lung Cancer Confirmed by Histopathology
2. Treated with Chemotherapy with or Without Checkpoint Inhibitors.
3. ECOG 0 - 1.
4. Predicted survival ≥ 12 weeks.
5. Adequate bone marrow hematopoiesis and organ function
6. Presence of measurable lesions according to RECIST 1.1.
7. Subjects with stable brain metastases may be included in the study.

Exclusion criteria

Patients did not match for the Inclusion Criteria.

Trial design

15,000 participants in 12 patient groups

Cohort A

Description:

Extansive Stage Small Cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors .

Treatment:

Drug: Immune checkpoint inhibitor

Cohort B

Description:

Limit Stage Small Celll Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors .

Treatment:

Drug: Immune checkpoint inhibitor

Cohort C

Description:

Small Celll Lung Cancer who progressed from first line treatment and received subsequential Chemotherapy with or without Checkpoint Inhibitors.

Treatment:

Drug: Immune checkpoint inhibitor

Cohort D

Description:

Metastastic Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.

Treatment:

Drug: Immune checkpoint inhibitor

Cohort E

Description:

Metastastic Non-small cell Lung Cancer who progressed from first line treatment and received subsequential Chemotherapy with or without Checkpoint Inhibitors.

Treatment:

Drug: Immune checkpoint inhibitor

Cohort F

Description:

Resectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.

Treatment:

Drug: Immune checkpoint inhibitor

Cohort G

Description:

Unresectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.

Treatment:

Drug: Immune checkpoint inhibitor

Cohort H

Description:

Non-small cell Lung Cancer received neoadjuvent or adjuvent Chemotherapy with or without Checkpoint Inhibitors.

Treatment:

Drug: Immune checkpoint inhibitor

Cohort I

Description:

Cohort I, Non-small cell Lung Cancer with EGFR, ALK and ROS1 sensitive mutation who received Chemotherapy with or without Checkpoint Inhibitors.

Treatment:

Drug: Immune checkpoint inhibitor

Cohort J

Description:

Non-small cell Lung Cancer with other oncogenic mutation including RET, BRAF etc who received Chemotherapy with or without Checkpoint Inhibitors.

Treatment:

Drug: Immune checkpoint inhibitor

Cohort K

Description:

Non-small cell Lung Cancer received Chemotherapy plus bevacizumab with or without Checkpoint Inhibitors.

Treatment:

Drug: Immune checkpoint inhibitor

Cohort L

Description:

Non-small cell Lung Cancer who enrolled in clinical trials.

Treatment:

Drug: Immune checkpoint inhibitor