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SHR0302 Combined With PD-1/PD-L1 Inhibition for Treatment naïve or Acquired Resistant to Immunology NSCLC

ConditionsNon-Small Cell Lung CancerJAK InhibitorImmunology
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChunxia Su

About this trial

Recent studies showed that the dysregulated activation of the JAK/STAT pathway, which leads to the prolonged release of IFN-γ, is a significant contributor to the resistance to immune checkpoint inhibitors in cancer immunotherapy. Preclinical and clinical studies have demonstrated that the combination of JAK inhibitors with PD-1 immunotherapy can reverse or delay onset of immunotherapy resistance by modulating the JAK/STAT pathway in Hodgkin's lymphoma and non - small cell lung cancer (NSCLC). SHR0302, being a highly selective JAK1 inhibitor, has shown excellent clinical benefits by effectively inhibiting the JAK/STAT pathway, leading to its approval for the treatment of Ankylosing Spondylitis in China. Preclinical studies also show that the combination of SHR0302 and PD-L1 inhibitor has synergistic potentials for anti-tumor effect in resistant to-immune checkpoint blockade patients. Thus, we conducted a phase 2 clinical trial evaluating SHR0302 combined with PD1/PD-L1 inhibitors as treatment-naïve or acquired resistant to first-line checkpoint inhibitor resistant NSCLC patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Inoperable or non-suitable for radical radiotherapy and chemotherapy IIIB/IIIC and Stage IV or metastatic non-small cell lung cancer (NSCLC)

Provide written informed consent for the trial.

Patients ≥ 18 years of age

Arm 1: treatment naive; Arm 2: acquired resistant to first-line PD-1/PD-L1 inhibition. Acquired resistance is defined as documented initial objective response (partial or complete response by RECIST or WHO) to therapy or significant and durable (> 6 months) clinical benefit (stable disease defined by RECIST or WHO).

Disqualifiers

Non-small cell cancer contains components of small cell lung cancer or neuroendocrine carcinoma.

Sensitizing mutations in Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) or ROS1 proto-oncogene receptor tyrosine kinase (ROS1) translocations;

Arm 1: Currently participating in or has participated in a study of an investigational agent or anticipated use of an investigational device within 4 weeks of the first dose of study treatment.

Receiving Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects within 2 weeks before the first administration.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PD-1 inhbitor+SHR0302

    Drug

    PD-1 inhbitor+SHR0302 in the maintenance treatment

  • PD-L1 inhibitor+SHR0302

    Drug

    PD-L1 inhibitor+SHR0302 in second line

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: Arm1- maintenance treatmentExperimental treatment 1 intervention
Group B: Arm2-Second line after first-line immunotherapy resistanceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival

PFS is defined as days from initiation of study therapy to first documented disease progression, death due to any cause or last subject contact which documents progression-free status.

Time frame
through study completion, an average of 18 months

Secondary outcomes

1

Objective response rate

Time frame
percentage of evaluable subjects who achieve a complete or partial clinical response at 12 weeks
2

Duration of Response

DOR is defined as the time from first documentation of partial or complete response to first documented disease progression.

Time frame
through study completion, an average of 18 months
3

Overall survival

OS is defined as days from initiation of study therapy to death due to any cause or last subject contact.

Time frame
through study completion, an average of 18 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chunxia Su

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: