Clinical trial NCT06216782: Exploring the Frontiers of Neoadjuvant Therapy for Lung Cancer: a Prospective Observational Real-world Study
Official title: Exploring the Frontiers of Neoadjuvant Therapy for Lung Cancer: a Prospective Observational Real-world Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: Neoadjuvant therapy; Lung cancer; Long-term survival
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received neoadjuvant therapy at Shanghai Pulmonary Hospital during the study period.

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.

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.

Primary outcomes:
measure: Event-free survival (EFS)
timeFrame: 5 years
Secondary outcomes:
measure: Surgical conversion rate and objective response rate (ORR)
timeFrame: 3 to 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Peng Zhang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: