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

NCT06216782 | Recruiting

• 1 other identifier: RW-LungMate
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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. 1.Primary research objective: to explore the therapeutic efficacy of patients with different characteristics under different neoadjuvant therapeutic regimens.
2. 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

Keywords

Neoadjuvant therapy; Lung cancer; Long-term survival

Outcome Measures

Primary Outcomes (1)

• Event-free survival (EFS)

  The time from diagnosis until progression, recurrence, or death from any cause.

  5 years

Secondary Outcomes (1)

• Surgical conversion rate and objective response rate (ORR)

  3 to 6 months

Study Arms (2)

Non-small cell lung cancer patients receiving neoadjuvant therapy

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

Other: Non-intervention

Small cell lung cancer patients receiving neoadjuvant therapy

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

Other: Non-intervention

Interventions

Non-intervention OTHER

Non-intervention

Non-small cell lung cancer patients receiving neoadjuvant therapy; Small cell lung cancer patients receiving neoadjuvant therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who received neoadjuvant therapy at Shanghai Pulmonary Hospital during the study period.

You may qualify if:

• Age greater than or equal to 18 years;
• Pathohistologically confirmed diagnosis of non-small cell lung cancer or small cell lung cancer;
• Received neoadjuvant therapy after diagnosis;
• Written informed consent.

You may not qualify if:

• Patients enrolled in other clinical trials;
• Patients refused enrollment in this study;
• Patients refused follow-up.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Peng Zhang, Ph.D.

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Zhang, Ph.D.

CONTACT

021-55672180; zhangpeng1121@tongji.edu.cn

Ziyun Shen, M.D.

CONTACT

021-55672180; shenzy94@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-President

Study Record Dates

• First Submitted: December 16, 2023
• First Posted: January 22, 2024
• Study Start: December 16, 2023
• Primary Completion (Estimated): December 30, 2033
• Study Completion (Estimated): December 30, 2033
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)