A phase I/II study to evaluate safety and efficacy of DCVAC/LuCa added to standard first line chemotherapy with carboplatin and paclitaxel +/- immune enhancers (interferon-a and hydroxychloroquine) vs chemotherapy alone in patients with Stage IV non-small cell lung cancer

Start Date16 Apr 2015

Sponsor / Collaborator

Excoso as

NCT02470468 / CompletedPhase 1/2

A Phase I/II Study to Evaluate Safety and Efficacy of DCVAC/LuCa Added to Standard First Line ChT With Carboplatin and Paclitaxel +/- Immune Enhancers (Interferon-α and Hydroxychloroquine) vs ChT Alone in Patients With Stage IV NSCLC

The purpose of the study is to compare efficacy of DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone in patients with stage IV NSCLC, as measured by progression free survival (PFS).

Start Date01 Dec 2014

Sponsor / Collaborator

Excoso as

100 Clinical Results associated with DCVAC/LuCa

100 Translational Medicine associated with DCVAC/LuCa

100 Patents (Medical) associated with DCVAC/LuCa

Literatures (Medical) associated with DCVAC/LuCa

01 Feb 2022·ESMO OpenQ3 · MEDICINE

Safety and efficacy of dendritic cell-based immunotherapy (DCVAC/LuCa) combined with carboplatin/pemetrexed for patients with advanced non-squamous non-small-cell lung cancer without oncogenic drivers

Q3 · MEDICINE

ArticleOA

Author: Han, B ; Zhong, R ; Xu, J ; Zhang, X ; Zhang, B ; Wang, H ; Ling, X ; Cao, S ; Zhong, H

BACKGROUNDOur prospective, open-label, single-arm phase II study investigated the safety and efficacy of DCVAC/LuCa (dendritic cell vaccines for lung cancer) combined with standard carboplatin/pemetrexed in advanced non-squamous (nsq) non-small-cell lung cancer (NSCLC).PATIENTS AND METHODSEligible patients had stage IV nsq NSCLC without oncogenic drivers and had not received prior systemic cancer therapy. Treatment consisted of carboplatin/pemetrexed for up to 6 cycles followed by 21 cycles of pemetrexed maintenance or until progression or intolerance. Non-progression patients after two cycles of chemotherapy started to receive DCVAC/LuCa subcutaneously (s.c.) on day 15 of cycle 3, and thereafter q3w (day 15 of chemotherapy cycles) for up to 15 doses. Dosing of DCVAC/LuCa s.c. varied among patients depending on the baseline number of leucocytes but remained constant for each single patient. Safety was assessed by adverse events (AEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs). Efficacy was measured by overall survival (OS), progression-free survival (PFS), time to progression (TTP), and objective response rate (ORR).RESULTSSixty-one patients were enrolled. In the safety population (n = 60), eight patients (13.33%) had grade 3 or greater TRAEs, and six patients (10.0%) showed SAEs which were not related to leukapheresis or DC vaccination. Six grade 1 AEs were considered to be related to leukapheresis. No AESIs or DCVAC/LuCa-induced AEs were observed. The 2-year survival rate in the modified intention-to-treat population (n = 44) was 52.57%. Median OS was not reached. Median PFS was 8.0 months, median TTP was 10.2 months, and the ORR was 31.82%.CONCLUSIONIn treatment-naïve stage IV nsq NSCLC patients without oncogenic drivers, the combination of carboplatin/pemetrexed and DCVAC/LuCa was well tolerated and showed promising efficacy. Therefore, a study to prove our immunotherapeutic concept in a randomized phase III trial is planned.

01 Jan 2022·Integrative Cancer TherapiesQ3 · MEDICINE

A Single-Arm Phase II Study to Evaluate Efficacy and Safety of First-Line Treatment With DCVAC/LuCa, Standard of Care Chemotherapy and Shenqi Fuzheng Injection in Advanced (Stage IIIB/IV) Non-Small Cell Lung Cancer Patients

Q3 · MEDICINE

Article

Author: Yan, Yongxia ; Li, Yuan ; Jia, Liqun ; Lou, Yanni ; Liu, Qing ; Cui, Huijuan ; Wan, Donggui ; Li, Liya ; Liu, Meng ; Yang, Guowang ; Deng, Chao ; Cheng, Zhiqiang

Objectives: To evaluate the efficacy and safety of first-line treatment with a dendritic cell vaccination for lung cancer (DCVAC/LuCa), standard of care chemotherapy and Shenqi Fuzheng injection in patients with advanced (stage IIIB/IV) non-small cell lung cancer. Patients and Methods: Patients with histologically or cytologically confirmed recurrent metastatic or advanced NSCLC (stage IIIB/IV) with wild-type epidermal growth factor receptor (EGFR) or EGFR mutation which does not confer increased tumor susceptibility to EGFR-interacting drugs were recruited. For the treatment period, the first cycle of standard of care therapy (SoC) started 2 to 14 days after the leukapheresis procedure. SoC continued 4 to 6 cycles. DCVAC/LuCa was administered from the second cycle of SoC. DCVAC/LuCa was administered in a 3-week cycle schedule (5 doses) and then in a 6-week cycle schedule. Shenqi Fuzheng injection was administered 3 days before each DCVAC/LuCa administration for a total of 14 daily doses. Patients would undergo disease evaluation by computed tomography (CT) scan every 3 months. The primary and secondary endpoint was efficacy with regard to objective response rate (ORR) and progression free survival (PFS). The safety profile was measured by: incidence, type, and severity of all adverse events (AEs), laboratory abnormalities (blood routine test, urine test, and chemical test), physical status, and vital signs. Qi insufficiency was evaluated by tongue diagnosis and questionnaire survey with “Classification and Determination of constitution in TCM.” Results: Twenty-three patients from 3 hospitals who received combination therapy were included. ORR was 34.8% (95% CI:16.4%-57.3%). Median duration of response was 5.51 m (95% CI:2.70-8.32). Median PFS was 10.72 m (95% CI:4.52-16.93), 1-year survival was 77.8%. mOS was 21.97 m (95% CI:13.68-30.25). There was 1 severe AE related to a history of heart disease and there were no adverse events related to DCVAC/LuCa treatment. Qi insufficiency was improved significantly ( P < .0001) from 41.19 ± 14.58 before treatment to 10.52 ± 16.58 after treatment. Conclusion: DCVAC/LuCa, combined with standard of care chemotherapy and Shenqi Fuzheng injection exhibited good benefit in Chinese patients with recurrent metastatic or advanced (stage IIIB/IV) NSCLC, and also significantly improved Qi insufficiency constitution. There were no related adverse events with DCVAC/LuCa treatment.

01 Jan 2021·Cancer Treatment and Research Communications

Autologous dendritic cell-based immunotherapy (DCVAC/LuCa) and carboplatin/paclitaxel in advanced non-small cell lung cancer: A randomized, open-label, phase I/II trial

Article

Author: Pesek, Milos ; Korolkiewicz, Roman P ; Lukesova, Sarka ; Spisek, Radek ; Vanasek, Jaroslav ; Koubkova, Leona ; Fricke, Harald ; Beniak, Juraj ; Skrickova, Jana ; Jakesova, Jitka ; Klepetko, Petr ; Bartunkova, Jirina ; Siskova, Lenka ; Reiterer, Pavel ; Kultan, Juraj ; Kadlecova, Pavla ; Bartek, Tomas ; Hraska, Marek ; Andrasina, Igor ; Salajka, Frantisek ; Zemanova, Milada ; Havel, Libor ; Cernovska, Marketa

PURPOSETo investigate the efficacy and safety of an active cellular immunotherapy (DCVAC/LuCa) and chemotherapy in patients with stage IV non-small cell lung cancer (NSCLC).PATIENTS AND METHODSSLU01 was a multicenter, open-label, parallel-group, randomized, phase I/II trial. NSCLC patients were randomized in a ratio of 1:1:1 to receive: DCVAC/LuCa and chemotherapy (carboplatin and paclitaxel; Group A); DCVAC/LuCa, chemotherapy, pegylated interferon-α2b, and hydroxychloroquine (Group B); or chemotherapy alone (Group C). DCVAC/LuCa was administered subcutaneously every 3-6 weeks (up to 15 doses). The primary endpoint was overall survival (OS). During the study, enrollment into Group B was discontinued for strategic reasons.RESULTSForty-five patients were randomized to Group A, 29 patients to Group B, and 38 patients to Group C. The median OS in the modified intention-to-treat (mITT) population was 3.7 months longer in Group A than in Group C (15.5 vs. 11.8 months; p = 0.0179; hazard ratio = 0.54; 95% confidence interval: 0.32-0.91). This OS effect was consistent across subgroups of the mITT population (females, males, current smokers, former smokers, and patients with non-squamous and squamous cell histology). The most common treatment-emergent adverse events of any grade reported in Groups A, B, and C, respectively, were neutropenia (50.0%, 29.6%, and 20.6%), fatigue (40.0%, 18.5%, and 20.6%), anemia (35.0%, 44.4%, and 32.4%), paresthesia (27.5%, 25.9%, and 17.6%), and alopecia (25.0%, 29.6%, and 41.2%).CONCLUSIONDCVAC/LuCa in combination with carboplatin and paclitaxel extended OS and was well tolerated.

100 Deals associated with DCVAC/LuCa

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Indication	Highest Phase	Country/Location	Organization	Date
metastatic non-small cell lung cancer	Phase 3	SK	Excoso as	01 Dec 2014
metastatic non-small cell lung cancer	Phase 3	CZ	Excoso as	01 Dec 2014
Secondary malignant neoplasm of lung	Phase 3	CZ	Excoso as	01 Dec 2014
Secondary malignant neoplasm of lung	Phase 3	SK	Excoso as	01 Dec 2014
Non-Small Cell Lung Cancer	Phase 3	-	Excoso as	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2020	Phase 2	Advanced Lung Non-Small Cell Carcinoma	23	DCVAC/LuCa plus chemotherapy and TCM	(lqopslexog) = cxttsbwitl evpkkboewh (bwkoeevgvd ) View more	Positive	25 May 2020

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