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NCT Number: NCT05557552

Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly And/or Frail Stage III Non-small-cell Lung Cancer

Concurrent chemoradiotherapy without disease progression followed by consolidation durvalumab is standard of care for unresectable, stage III non-small-cell lung cancer (NSCLC) (the 'PACIFIC regimen'). However, many patients with poor performance status, older age or comorbidities may be ineligible for chemotherapy due to expected high toxicity. The present study aim to investigate the efficacy and toxicities of sequential chemo-immunotherapy plus thoracic radiotherapy for elderly and/or frail stage III NSCLC patients unfit for concurrent chemoradiotherapy, and to identify the optimal thoracic dose for this patient population.

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Key information

Conditions

Non-small Cell Lung Cancer Stage III Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital, Shanghai jiaotong univestigy school of medicine

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Shengguang Zhao, Dr

CONTACT

Yi Xiang, Dr.

CONTACT

Yifeng Wang

CONTACT

[email protected]

+862164370045

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years at time of study entry
  • Histologically documented diagnosis of unresectable stage III NSCLC;
  • Fully-informed written consent obtained from patients;
  • Unfit for concurrent chemoradiotherapy as determined by the multi-disciplinary team board due to one of the following reasons: (1) ECOG 2; (2)age≥70;(3) ECOG 1 and CCI≥1；
  • Adequate bone marrow, liver and kidney function
  • Life expectancy of at least 3 months
  • At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated
  • Histologic or cytologic confirmation of small cell lung cancer
  • Adequate pulmonary function with FEV1 >1 L or >30 % of predicted value and DLCO >30 % of predicted value

Exclusion criteria

  • Previous chemo-, immuno- or radiotherapy for NSCLC
  • Major surgical procedure last 28 days
  • History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV
  • Uncontrolled intercurrent illness
  • Other active malignancy
  • Leptomeningeal carcinomatosis
  • Immunosuppressive medication
  • Pregnant or breastfeeding women

Treatment and study plan

standar thoracic RT dose

Radiation

All the enrolled patients will be patients with NSCLC who did not have PD (determined as per the RECIST v1.1) after 4-6 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, those enrolled patients would be treated with standard dose thoracic radiotherapy of 60 Gy/30Fx concurrently with PD-1/PD-L1 maintenance therapy, and the total maintenance therapy time should at least more than 6 months.

decreased thoracic RT dose

Radiation

All the enrolled patients will be patients with NSCLC who did not have PD (determined as per the RECIST v1.1) after 4-6 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, those enrolled patients would be treated with decreased thoracic radiotherapy of 50Gy/25Fx concurrently with PD-1/PD-L1 maintenance therapy, and the total maintenance therapy time should at least more than 6 months.

Primary outcomes

  1. progression-free survival

    Time frame: 12 months after last patient entry

    time from treatment start until death or progression of tumor disease within one year

Secondary outcomes

  1. 1-year overall survial

    Time frame: 12 months after last patient entry

    time from treatment start until death with in one year

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 within one year

    Time frame: 12 months after last patient entry

    Safety and Tolerability

  3. 5-year overall survival

    Time frame: 5-years after last patient entry

    Time from treatment start until death

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly And/or Frail Stage III Non-small-cell Lung Cancer Patients Unfit for Concurrent Chemoradiotherapy: an Open Label, Two Cohorts, Prospective Trial

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Sep 28, 2022
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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