Exploring the Frontiers of Neoadjuvant Therapy for Lung Cancer: a Prospective Observational Real-world Study

NCT ID: NCT06216782

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-16
• Study Completion Date: 2033-12-30

Brief Summary

Lung cancer is a malignant tumor with the highest incidence and mortality rate of cancer patients worldwide. Traditional treatments for lung cancer include surgery, radiotherapy and chemotherapy, etc. Although the growth and spread of the tumor can be controlled to a certain extent, the cure rate for patients with progressive stage is still low and the prognosis is poor.

Neoadjuvant therapy intends to use chemotherapy, immunotherapy, and targeted therapy to reduce the size and load of the tumor before surgery, to improve the surgical resection rate and therapeutic effect.

1. Primary research objective: to explore the therapeutic efficacy of patients with different characteristics under different neoadjuvant therapeutic regimens.

2. Secondary objectives To investigate the strengths and weaknesses of different neoadjuvant regimens in real-world clinical practice, and to investigate the long-term outcomes of patients treated with different regimens.

Detailed Description

Lung cancer is a malignant tumor with the highest incidence and mortality rate of cancer patients worldwide. Traditional treatments for lung cancer include surgery, radiotherapy and chemotherapy, etc. Although the growth and spread of the tumor can be controlled to a certain extent, the cure rate for patients with progressive stage is still low and the prognosis is poor.

Neoadjuvant therapy intends to use chemotherapy, immunotherapy, and targeted therapy to reduce the size and load of the tumor before surgery, to improve the surgical resection rate and therapeutic effect. In lung cancer treatment, neoadjuvant therapy has rate and quality of life. However, a meta-analysis confirmed that although neoadjuvant chemotherapy can significantly improve survival compared to surgery alone, with an OS HR of 0.8, the improvement in 5-year survival is only 5%. Neoadjuvant radiotherapy alone, even if it can lead to pathological remission in resected specimens, does not improve resectability or overall survival. The goal of preoperative radiotherapy is to improve OS by reducing local tumor recurrence, which is the primary goal in patients with Pancoast syndrome, for example, in whom localized lung loss has an impact on quality of life. In the literature, it has been reported that in the early treatment experience of patients with Pancoast syndrome, the percentage of incompletely resected tumors was reduced by neoadjuvant radiotherapy. The MPR or pCR rate of neoadjuvant NSCLC treatment with conventional chemotherapy and radiotherapy is less than 10%, and the improvement in 5-year overall survival is only 5%, suggesting that its efficacy is very limited.

1. Primary objective The primary objective of the study is to explore the efficacy of neoadjuvant therapy in patients with different characteristics under different neoadjuvant therapy regimens.

2. Secondary objectives To investigate the strengths and weaknesses of different neoadjuvant regimens in real-world clinical practice, and to investigate the long-term outcomes of patients treated with different regimens.

Conditions

Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-small cell lung cancer patients receiving neoadjuvant therapy

Patients diagnosed with non-small cell lung cancer who received neoadjuvant therapy.

Non-intervention

Intervention Type: OTHER

Non-intervention

Small cell lung cancer patients receiving neoadjuvant therapy

Patients diagnosed with small cell lung cancer who received neoadjuvant therapy.

Non-intervention

Intervention Type: OTHER

Non-intervention

Interventions

Non-intervention

Non-intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age greater than or equal to 18 years;

2. Pathohistologically confirmed diagnosis of non-small cell lung cancer or small cell lung cancer;

3. Received neoadjuvant therapy after diagnosis;

4. Written informed consent.

Exclusion Criteria

1. Patients enrolled in other clinical trials;

2. Patients refused enrollment in this study;

3. Patients refused follow-up.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: lead

Responsible Party

Peng Zhang

Vice-President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peng Zhang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital, Shanghai, China

Locations

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Peng Zhang, Ph.D.

Role: CONTACT

zhangpeng1121@tongji.edu.cn

021-55672180

Ziyun Shen, M.D.

Role: CONTACT

shenzy94@126.com

021-55672180

Facility Contacts

Peng Zhang, Ph.D.

Role: primary

zhangpeng1121@tongji.edu.cn

021-55672180

Other Identifiers

RW-LungMate

Identifier Type: -

Identifier Source: org_study_id