Abstract illustration of lung cancer treatment research.

SHR-1210: Revolutionizing First-Line Lung Cancer Treatment?

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Nico Varela in Health & Wellness December 2025 • 4 min read.

"A phase III trial explores a novel combination therapy for advanced non-squamous non-small cell lung cancer, offering hope for improved outcomes."


Lung cancer remains a leading cause of cancer-related deaths worldwide, with non-small cell lung cancer (NSCLC) being the most prevalent subtype. For patients with advanced or metastatic non-squamous NSCLC, first-line treatment options are crucial in improving survival rates and quality of life. Researchers are continuously exploring novel therapeutic strategies to overcome the limitations of existing treatments.

Immunotherapy, particularly the use of anti-PD-1 antibodies, has emerged as a promising approach in cancer treatment. These antibodies work by blocking the interaction between PD-1 (programmed cell death protein 1) and its ligand, PD-L1, thereby unleashing the immune system to attack cancer cells. SHR-1210 is a humanized anti-PD-1 antibody that has shown potential in preclinical studies.

A phase III clinical trial is underway to evaluate the efficacy and safety of SHR-1210 in combination with pemetrexed and carboplatin, two commonly used chemotherapy drugs, as a first-line treatment for patients with advanced or metastatic non-squamous NSCLC. This article delves into the design and rationale behind this study, shedding light on the potential of SHR-1210 to revolutionize lung cancer therapy.

The SHR-1210 Clinical Trial: A Detailed Look

Abstract illustration of lung cancer treatment research.

The clinical trial, named 'A phase III, randomized, open-label, multicenter study of SHR-1210 (anti-PD-1 antibody) in combination with pemetrexed and carboplatin as first line therapy in subjects with advanced/metastatic non-squamous non-small cell lung cancer', is designed to assess whether adding SHR-1210 to standard chemotherapy can improve outcomes for patients with advanced non-squamous NSCLC. The trial involves multiple centers and follows an open-label design, meaning both the researchers and participants are aware of the treatment being administered.

A total of 412 patients will be enrolled and randomly assigned in a 1:1 ratio to one of two treatment arms:

  • Chemotherapy Alone: Patients receive carboplatin and pemetrexed, administered intravenously every three weeks for 4-6 cycles, followed by pemetrexed maintenance therapy.
  • SHR-1210 Combination: Patients receive carboplatin and pemetrexed, plus SHR-1210, administered intravenously every three weeks for up to 35 cycles.
Patients in the chemotherapy-alone arm have the option to crossover to receive SHR-1210 monotherapy upon disease progression, provided they meet specific criteria. This crossover design allows researchers to gather additional data on the effectiveness of SHR-1210 as a second-line treatment. The primary goal of the study is to evaluate the progression-free survival (PFS) - which defined as the time from randomization to disease progression or death.

The Future of Lung Cancer Therapy?

The results of this phase III clinical trial will provide valuable insights into the potential of SHR-1210 as a first-line treatment for advanced non-squamous NSCLC. If the combination therapy proves to be effective, it could offer a new treatment option for patients with this challenging disease.

Furthermore, the study design, including the crossover arm, allows for a comprehensive evaluation of SHR-1210's efficacy in both first-line and second-line settings. This approach could help guide future treatment strategies and improve patient outcomes.

As research in immunotherapy continues to advance, it is crucial to explore novel combinations and personalized approaches to optimize treatment efficacy and minimize side effects. The SHR-1210 clinical trial represents an important step forward in the fight against lung cancer, potentially paving the way for more effective and targeted therapies.

About this Article -

This article was crafted using a human-AI hybrid and collaborative approach. AI assisted our team with initial drafting, research insights, identifying key questions, and image generation. Our human editors guided topic selection, defined the angle, structured the content, ensured factual accuracy and relevance, refined the tone, and conducted thorough editing to deliver helpful, high-quality information.See our About page for more information.

Everything You Need To Know

1

How does SHR-1210 work to fight lung cancer, and what is its target?

SHR-1210 is a humanized anti-PD-1 antibody. It works by blocking the interaction between PD-1 (programmed cell death protein 1) and its ligand, PD-L1. This action unleashes the immune system to recognize and attack cancer cells. This mechanism is crucial because cancer cells often evade immune detection by exploiting the PD-1/PD-L1 pathway.

2

What is the design of the SHR-1210 clinical trial for non-small cell lung cancer, and what makes it unique?

The clinical trial is designed as a phase III, randomized, open-label, multicenter study. It compares the effectiveness of chemotherapy alone (carboplatin and pemetrexed) versus chemotherapy combined with SHR-1210 as a first-line treatment. The open-label design means that both researchers and participants know which treatment is being administered. Patients receiving only chemotherapy can switch to SHR-1210 monotherapy if their disease progresses.

3

What is the primary goal of the SHR-1210 clinical trial, and how is it measured?

The main goal of the clinical trial is to determine if adding SHR-1210 to the standard chemotherapy regimen of carboplatin and pemetrexed improves progression-free survival (PFS). PFS is measured as the time from when a patient is enrolled in the study to when their disease progresses or they pass away. Observing improvements in PFS would suggest that the addition of SHR-1210 is beneficial in controlling the cancer.

4

How many patients are involved in the SHR-1210 clinical trial, and what are the treatment arms?

The trial involves 412 patients with advanced or metastatic non-squamous non-small cell lung cancer. Participants are randomly assigned in a 1:1 ratio to either receive carboplatin and pemetrexed alone or carboplatin and pemetrexed in combination with SHR-1210. The chemotherapy is administered every three weeks for 4-6 cycles, followed by pemetrexed maintenance therapy in the chemotherapy-alone arm, while the SHR-1210 combination arm receives treatment for up to 35 cycles. The size of the trial increases the validity of the conclusions.

5

What are the potential implications if the SHR-1210 clinical trial is successful?

If the phase III clinical trial demonstrates that the combination of SHR-1210 with carboplatin and pemetrexed is effective, it could revolutionize the treatment landscape for advanced non-squamous NSCLC. This could lead to a new first-line treatment option, potentially improving survival rates and quality of life for patients. The results would pave the way for regulatory approvals and wider clinical adoption, impacting how lung cancer is managed globally. However, the study only investigates this combination for non-squamous NSCLC, and further research would be needed to determine its effectiveness in other types of lung cancer.

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