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Durvalumab plus chemotherapy shows 35% response in phase II trial for metastatic pulmonary sarcomatoid carcinomaSmall study tests drug combination for rare, aggressive lung cancer

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Key Takeaway
Consider early-phase data on durvalumab-chemotherapy for pulmonary sarcomatoid carcinoma as preliminary and requiring validation.

A prematurely terminated phase II single-arm trial evaluated the combination of durvalumab (1500 mg every 3 weeks), doxorubicin (20 mg/m², days 1-3), and ifosfamide (1.5 g/m², days 2-4) for up to four cycles, followed by durvalumab monotherapy, in 20 patients with recurrent or metastatic pulmonary sarcomatoid carcinoma. The median follow-up was 7.0 months.

The primary outcome, objective response rate, was 35.0% (7 out of 20 patients; 95% CI, 17.7%-55.8%). The median duration of response was 5.3 months (95% CI, 1.7-not estimated). Median progression-free survival was 4.8 months (95% CI, 2.0-6.5), and median overall survival was 9.4 months (95% CI, 5.5-26.8).

Regarding safety, adverse events occurred in 19 patients, with serious adverse events in 10 patients. Discontinuation rates and detailed tolerability were not reported. The study was terminated early due to low recruitment, which is a major limitation alongside the small sample size, single-arm design, and lack of a comparator group.

This trial suggests preliminary clinical activity for the combination in a difficult-to-treat malignancy. However, the evidence is early and insufficient to establish efficacy or safety. The findings should be interpreted as hypothesis-generating, and larger, controlled studies are warranted to confirm any benefit and refine treatment strategies.

Researchers conducted a small, early-stage (Phase II) clinical trial to see if a combination of three drugs—durvalumab, doxorubicin, and ifosfamide—could help patients with a rare and hard-to-treat lung cancer called recurrent or metastatic pulmonary sarcomatoid carcinoma. The study included 20 patients who received the drug combination for up to four cycles, followed by one of the drugs alone for up to a year.

The main finding was that 7 out of the 20 patients (35%) experienced a measurable shrinkage of their tumors. For those who responded, the benefit lasted a median of about 5.3 months. The median time before the cancer started growing again was 4.8 months, and the median overall survival was 9.4 months. The study also reported that side effects were common, with serious adverse events occurring in half of the patients.

It is very important to interpret these results with caution. This was a small, single-arm study, meaning there was no comparison group to see if patients would have done just as well with a different treatment. The trial was also stopped early because of difficulty finding enough patients to enroll. While the results suggest this combination might have some activity against this rare cancer, they are not definitive. Larger, more robust studies are needed to confirm if this is a helpful treatment approach and to better understand its safety profile.

What this means for you:
Early, small study in rare lung cancer shows some tumor response; more research is needed.

Study Details

Study typePhase2
Sample sizen = 20
EvidenceLevel 3
Follow-up0.7 mo
PublishedApr 2026
View Original Abstract ↓
BACKGROUND: Pulmonary sarcomatoid carcinomas (PSCs) are rare, aggressive tumors with a poor prognosis. Conventional chemotherapy shows limited efficacy, whereas immune checkpoint inhibitors and doxorubicin have shown potential. This study evaluated the efficacy and safety of durvalumab, doxorubicin, and ifosfamide in recurrent and/or metastatic PSC. PATIENTS AND METHODS: Patients with recurrent or metastatic PSC received durvalumab (1500 mg, day 1), doxorubicin (20 mg/m² intravenously, days 1-3), and ifosfamide (1.5 g/m² intravenously with mesna, days 2-4) every 3 weeks for up to four cycles, followed by durvalumab monotherapy until disease progression or unacceptable toxicity, for up to 12 months. The primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), duration of response (DOR), and toxicity. RESULTS: The study was prematurely terminated due to low recruitment rates, with 20 patients enrolled (15 male, 5 female; median age: 63.5 years). Among 18 evaluable cases, 16 (88.9%) were programmed death-ligand 1 positive. Six patients (30.0%) had prior palliative chemotherapy. ORR was 35.0% (95% CI, 17.7%-55.8%). The median DOR was 5.3 months (95% CI, 1.7-not estimated). After a median follow-up of 7.0 months (1.2-37.6), the median PFS and OS were 4.8 months (95% CI, 2.0-6.5) and 9.4 months (95% CI, 5.5-26.8), respectively. Adverse events (AEs) occurred in 19 patients, with serious AEs in 10 patients. CONCLUSION: Durvalumab combined with doxorubicin and ifosfamide suggested clinical activity in recurrent and/or metastatic PSC. Larger studies are warranted to confirm benefits and refine treatment strategies.
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